Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    A Multicenter, Randomized, Open-Label, Blinded Endpoint Evaluation, Active-Controlled, Dose-Ranging Study to Compare the Efficacy and Safety of i.v. MAA868 and s.c. Enoxaparin in Adult Patients Undergoing Elective Unilateral Total Knee Arthroplasty

    Summary
    EudraCT number
    		 2019-003756-37
    Trial protocol
    		 LT   BE   LV   BG  
    Global end of trial date
    12 Mar 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    03 Dec 2021
    First version publication date
    03 Dec 2021
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    ANT-005
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Other trial identifiers
    		 IND Number: : 129008
    Sponsors
    Sponsor organisation name
    Anthos Therapeutics
    Sponsor organisation address
    55 Cambridge Pkwy, Suite 103, Cambridge, United States, MA 02142
    Public contact
    Information Desk, Anthos Therapeutics, Inc., +1 617-430-6940, info@anthostherapeutics.com
    Scientific contact
    Information Desk, Anthos Therapeutics, Inc., +1 617-430-6940, info@anthostherapeutics.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    23 Aug 2021
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    12 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    12 Mar 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    • To assess if at least one dose of MAA868 is non-inferior to enoxaparin 40 mg through Day 10 after randomization in terms of incidence of adjudicated total VTE in patients undergoing unilateral TKA.
    Protection of trial subjects
    The protocol and amendments were reviewed and approved by the relevant Ethics Committees (ECs) or Institutional Review Boards (IRBs) for each study site. The study was conducted in accordance with the Declaration of Helsinki and its most recent update, and the International Council for Harmonisation (ICH) E6 Good Clinical Practice (GCP) guideline. The study was also conducted in accordance with local legal and regulatory requirements of the country (or countries) involved, and with Standard Operating Procedures in place. A Steering and Safety Committee (SSC) in collaboration with the sponsor (Anthos Therapeutics) was responsible for study design and oversight. The SSC was set up to review aggregated data for total VTE, total bleeding events, and other safety events unblinded to treatment assignment. The Informed Consent Form (ICF) was approved by the Investigator’s local IRB or EC before patients were enrolled and written informed consent for the study was obtained from all patients before protocol-specific procedures were carried out. The Investigator (or designee) explained the nature of the study and its purpose, the procedures, expected duration, potential risks and benefits, potential alternative procedures, the action of the test product, and the extent of maintaining the confidentiality of the patient’s records. Patients were informed that participation was voluntary and that they could withdraw from the study at any time. The informed consent process was documented by the use of a written ICF approved by the designated IRB or EC and was signed by the patient (or patient’s legal representative, or legal guardian). The patient was given a copy of the signed ICF.
    Background therapy
    		 -
    Evidence for comparator
    		 Enoxaparin sodium (40 mg s.c.) was used as comparator, in accordance with the local country requirements and regulations. Enoxaparin, a low-molecular-weight heparin, is commonly used for the prevention of VTE after TKA. Enoxaparin has a predictable pharmacokinetic (PK) profile and dose-response relationship, allowing simplified dosing without the need for monitoring.
    Actual start date of recruitment
    20 May 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Bulgaria: 4
    Country: Number of subjects enrolled
    Latvia: 256
    Country: Number of subjects enrolled
    Lithuania: 92
    Country: Number of subjects enrolled
    Russian Federation: 1
    Country: Number of subjects enrolled
    Ukraine: 59
    Worldwide total number of subjects
    412
    EEA total number of subjects
    352
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    156
    From 65 to 84 years
    256
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 Male and female patients (≥18 and <80 years old) scheduled to undergo elective unilateral total knee arthroplasty with a body weight between 50 and 130 kg, inclusive.

    Pre-assignment
    Screening details
    		 Patients underwent screening assessments during the screening period (Day -30 to Day -1). The Investigator verified that they were eligible per criteria, patients who met the eligibility criteria were randomized to 1 of the 4 treatment groups.

    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    This study was open label with regard to MAA868 versus enoxaparin but blinded to the dose of MAA868. Blinded randomization schedule and procedures were used as outlined in the Statistical Analysis Plan (SAP).

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 MAA868 30 mg
    Arm description
    		 MAA868 30 mg i.v.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abelacimab
    Investigational medicinal product code
    MAA868
    Other name
    MAA868
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    MAA868 as liquid in vial concentrate (150 mg/mL). Dose groups were administered as single i.v. administrations approximately 4 to 8 hours after surgical wound closure, but no less than 4 hours after the removal of an epidural catheter.

    Arm title
    		 MAA868 75 mg
    Arm description
    		 MAA868 75 mg i.v.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abelacimab
    Investigational medicinal product code
    MAA868
    Other name
    MAA868
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    MAA868 as liquid in vial concentrate (150 mg/mL). Dose groups were administered as single i.v. administrations approximately 4 to 8 hours after surgical wound closure, but no less than 4 hours after the removal of an epidural catheter.

    Arm title
    		 MAA868 150 mg
    Arm description
    		 MAA868 150 mg i.v.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Abelacimab
    Investigational medicinal product code
    MAA868
    Other name
    MAA868
    Pharmaceutical forms
    Concentrate and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    MAA868 as liquid in vial concentrate (150 mg/mL). Dose groups were administered as single i.v. administrations approximately 4 to 8 hours after surgical wound closure, but no less than 4 hours after the removal of an epidural catheter.

    Arm title
    		 Enoxaparin
    Arm description
    		 Enoxaparin 40 mg s.c.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Enoxaparin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Enoxaparin 40 mg was administered subcutaneously starting approximately 12 hours after TKA surgery followed by daily s.c. injections of 40 mg enoxaparin up to the visit Day 10 venography. A single initial 40 mg s.c. enoxaparin dose prior to TKA surgery may have been given at the discretion of the Investigator per local guidelines.

    Number of subjects in period 1
    		MAA868 30 mg MAA868 75 mg MAA868 150 mg Enoxaparin
    Started
    104
    105
    100
    103
    Completed
    103
    102
    99
    103
    Not completed
    1
    3
    1
    0
         Consent withdrawn by subject
    -
    1
    1
    -
         Physician decision
    -
    1
    -
    -
         Adverse event, non-fatal
    1
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    MAA868 30 mg
    Reporting group description
    		 MAA868 30 mg i.v.

    Reporting group title
    MAA868 75 mg
    Reporting group description
    		 MAA868 75 mg i.v.

    Reporting group title
    MAA868 150 mg
    Reporting group description
    		 MAA868 150 mg i.v.

    Reporting group title
    Enoxaparin
    Reporting group description
    		 Enoxaparin 40 mg s.c.

    Reporting group values
    		 MAA868 30 mg MAA868 75 mg MAA868 150 mg Enoxaparin Total
    Number of subjects
    		 104 105 100 103 412
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0 0 0
        Newborns (0-27 days)
    		 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0 0 0
        Children (2-11 years)
    		 0 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0 0
        Adults (18-64 years)
    		 40 43 32 41 156
        From 65-84 years
    		 64 62 68 62 256
        85 years and over
    		 0 0 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 66.5 ( 7.41 ) 66.5 ( 7.96 ) 67.7 ( 6.69 ) 65.9 ( 8.07 ) -
    Gender categorical
    Units: Subjects
        Female
    		 90 85 78 82 335
        Male
    		 14 20 22 21 77
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 0 0 0 0 0
        Not Hispanic or Latino
    		 104 105 100 103 412
        Unknown
    		 0 0 0 0 0
    Race
    Units: Subjects
        White
    		 104 105 100 103 412
        Black or African American
    		 0 0 0 0 0
        Asian
    		 0 0 0 0 0
        Native Hawaiian or Other Pacific Islander
    		 0 0 0 0 0
        American Indian or Alaska Native
    		 0 0 0 0 0
        Other
    		 0 0 0 0 0
    Height
    Units: cm
        arithmetic mean (standard deviation)
    		 164.35 ( 7.913 ) 164.90 ( 9.053 ) 165.17 ( 8.284 ) 164.67 ( 8.095 ) -
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    		 91.810 ( 17.4128 ) 89.686 ( 15.2486 ) 89.995 ( 14.7515 ) 93.956 ( 15.2836 ) -
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    		 33.952 ( 5.8979 ) 33.062 ( 5.5630 ) 33.039 ( 5.2556 ) 34.651 ( 5.1765 ) -
    Subject analysis sets

    Subject analysis set title
    MAA868 30 mg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set included randomized patients who received at least one dose of study drug. Patients were analyzed based on the actual treatment taken.

    Subject analysis set title
    MAA868 75 mg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set included randomized patients who received at least one dose of study drug. Patients were analyzed based on the actual treatment taken.

    Subject analysis set title
    MAA868 150 mg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set included randomized patients who received at least one dose of study drug. Patients were analyzed based on the actual treatment taken.

    Subject analysis set title
    Enoxaparin 40 mg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set included randomized patients who received at least one dose of study drug. Patients were analyzed based on the actual treatment taken.

    Subject analysis set title
    MAA868 30 mg mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent-to-Treat (mITT) Population included all patients who were randomized and received at least 1 dose of the assigned study drug and were evaluable for the primary efficacy outcome (ie, the patient had either an evaluable venogram or had an objectively confirmed symptomatic VTE event, a VTE-related death, or a death for which PE could not be excluded). For all efficacy analyses, the main analysis was based on the mITT Population.

    Subject analysis set title
    MAA868 75 mg mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent-to-Treat (mITT) Population included all patients who were randomized and received at least 1 dose of the assigned study drug and were evaluable for the primary efficacy outcome (ie, the patient had either an evaluable venogram or had an objectively confirmed symptomatic VTE event, a VTE-related death, or a death for which PE could not be excluded). For all efficacy analyses, the main analysis was based on the mITT Population.

    Subject analysis set title
    MAA868 150 mg mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent-to-Treat (mITT) Population included all patients who were randomized and received at least 1 dose of the assigned study drug and were evaluable for the primary efficacy outcome (ie, the patient had either an evaluable venogram or had an objectively confirmed symptomatic VTE event, a VTE-related death, or a death for which PE could not be excluded). For all efficacy analyses, the main analysis was based on the mITT Population.

    Subject analysis set title
    Enoxaparin 40 mg mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent-to-Treat (mITT) Population included all patients who were randomized and received at least 1 dose of the assigned study drug and were evaluable for the primary efficacy outcome (ie, the patient had either an evaluable venogram or had an objectively confirmed symptomatic VTE event, a VTE-related death, or a death for which PE could not be excluded). For all efficacy analyses, the main analysis was based on the mITT Population.

    Subject analysis sets values
    		 MAA868 30 mg Safety MAA868 75 mg Safety MAA868 150 mg Safety Enoxaparin 40 mg Safety MAA868 30 mg mITT MAA868 75 mg mITT MAA868 150 mg mITT Enoxaparin 40 mg mITT
    Number of subjects
    102
    104
    99
    104
    102
    99
    98
    101
    Age categorical
    Units: Subjects
        In utero
    0
    0
    0
    0
    0
    0
    0
    0
        Preterm newborn infants (gestational age < 37 wks)
    0
    0
    0
    0
    0
    0
    0
    0
        Newborns (0-27 days)
    0
    0
    0
    0
    0
    0
    0
    0
        Infants and toddlers (28 days-23 months)
    0
    0
    0
    0
    0
    0
    0
    0
        Children (2-11 years)
    0
    0
    0
    0
    0
    0
    0
    0
        Adolescents (12-17 years)
    0
    0
    0
    0
    0
    0
    0
    0
        Adults (18-64 years)
    39
    42
    33
    41
    39
    41
    32
    40
        From 65-84 years
    63
    62
    66
    63
    63
    58
    66
    61
        85 years and over
    0
    0
    0
    0
    0
    0
    0
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    66.4 ( 7.36 )
    66.7 ( 7.71 )
    67.6 ( 6.71 )
    65.9 ( 8.03 )
    66.5 ( 7.33 )
    66.4 ( 7.71 )
    67.6 ( 6.71 )
    66.1 ( 7.91 )
    Gender categorical
    Units: Subjects
        Female
    89
    85
    77
    83
    89
    80
    77
    81
        Male
    13
    19
    22
    21
    13
    19
    21
    20
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    0
    0
    0
    0
    0
    0
    0
    0
        Not Hispanic or Latino
    102
    104
    99
    104
    102
    99
    98
    101
        Unknown
    0
    0
    0
    0
    0
    0
    0
    0
    Race
    Units: Subjects
        White
    102
    104
    99
    104
    102
    99
    98
    101
        Black or African American
    0
    0
    0
    0
    0
    0
    0
    0
        Asian
    0
    0
    0
    0
    0
    0
    0
    0
        Native Hawaiian or Other Pacific Islander
    0
    0
    0
    0
    0
    0
    0
    0
        American Indian or Alaska Native
    0
    0
    0
    0
    0
    0
    0
    0
        Other
    0
    0
    0
    0
    0
    0
    0
    0
    Height
    Units: cm
        arithmetic mean (standard deviation)
    164.20 ( 7.897 )
    164.76 ( 8.973 )
    165.12 ( 8.312 )
    164.72 ( 8.073 )
    164.21 ( 7.911 )
    164.80 ( 9.023 )
    165.06 ( 8.296 )
    164.53 ( 8.115 )
    Weight
    Units: kg
        arithmetic mean (standard deviation)
    91.628 ( 17.4793 )
    89.644 ( 15.3165 )
    90.376 ( 14.8977 )
    93.777 ( 15.3188 )
    91.588 ( 17.4295 )
    89.825 ( 15.5015 )
    89.993 ( 14.8998 )
    94.162 ( 15.3368 )
    Body Mass Index
    Units: kg/m2
        arithmetic mean (standard deviation)
    33.950 ( 5.9508 )
    33.101 ( 5.5755 )
    33.184 ( 5.2197 )
    34.569 ( 5.2198 )
    33.933 ( 5.9427 )
    33.145 ( 5.5983 )
    33.078 ( 5.2878 )
    34.774 ( 5.1384 )

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    MAA868 30 mg
    Reporting group description
    		 MAA868 30 mg i.v.

    Reporting group title
    MAA868 75 mg
    Reporting group description
    		 MAA868 75 mg i.v.

    Reporting group title
    MAA868 150 mg
    Reporting group description
    		 MAA868 150 mg i.v.

    Reporting group title
    Enoxaparin
    Reporting group description
    		 Enoxaparin 40 mg s.c.

    Subject analysis set title
    MAA868 30 mg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set included randomized patients who received at least one dose of study drug. Patients were analyzed based on the actual treatment taken.

    Subject analysis set title
    MAA868 75 mg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set included randomized patients who received at least one dose of study drug. Patients were analyzed based on the actual treatment taken.

    Subject analysis set title
    MAA868 150 mg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set included randomized patients who received at least one dose of study drug. Patients were analyzed based on the actual treatment taken.

    Subject analysis set title
    Enoxaparin 40 mg Safety
    Subject analysis set type
    		 Safety analysis
    Subject analysis set description
    The Safety Set included randomized patients who received at least one dose of study drug. Patients were analyzed based on the actual treatment taken.

    Subject analysis set title
    MAA868 30 mg mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent-to-Treat (mITT) Population included all patients who were randomized and received at least 1 dose of the assigned study drug and were evaluable for the primary efficacy outcome (ie, the patient had either an evaluable venogram or had an objectively confirmed symptomatic VTE event, a VTE-related death, or a death for which PE could not be excluded). For all efficacy analyses, the main analysis was based on the mITT Population.

    Subject analysis set title
    MAA868 75 mg mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent-to-Treat (mITT) Population included all patients who were randomized and received at least 1 dose of the assigned study drug and were evaluable for the primary efficacy outcome (ie, the patient had either an evaluable venogram or had an objectively confirmed symptomatic VTE event, a VTE-related death, or a death for which PE could not be excluded). For all efficacy analyses, the main analysis was based on the mITT Population.

    Subject analysis set title
    MAA868 150 mg mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent-to-Treat (mITT) Population included all patients who were randomized and received at least 1 dose of the assigned study drug and were evaluable for the primary efficacy outcome (ie, the patient had either an evaluable venogram or had an objectively confirmed symptomatic VTE event, a VTE-related death, or a death for which PE could not be excluded). For all efficacy analyses, the main analysis was based on the mITT Population.

    Subject analysis set title
    Enoxaparin 40 mg mITT
    Subject analysis set type
    		 Modified intention-to-treat
    Subject analysis set description
    The Modified Intent-to-Treat (mITT) Population included all patients who were randomized and received at least 1 dose of the assigned study drug and were evaluable for the primary efficacy outcome (ie, the patient had either an evaluable venogram or had an objectively confirmed symptomatic VTE event, a VTE-related death, or a death for which PE could not be excluded). For all efficacy analyses, the main analysis was based on the mITT Population.

    Primary: Primary Endpoint

    		 Close Top of page
    End point title
    		 Primary Endpoint
    End point description
    The primary efficacy endpoints included occurrence of confirmed composite endpoint of asymptomatic DVT on the protocol required venography, confirmed symptomatic VTE (including confirmed symptomatic DVT of the leg, fatal or non-fatal PE), or unexplained death for which PE could not be ruled out during treatment through Day 10.
    End point type
    Primary
    End point timeframe
    During the treatment period (Days 0 through 10)
    End point values
    		 MAA868 30 mg mITT MAA868 75 mg mITT MAA868 150 mg mITT Enoxaparin 40 mg mITT
    Number of subjects analysed
    102
    99
    98
    101
    Units: number
    13
    5
    4
    22
    Statistical analysis title
    		 % Difference vs Enoxaparin(95% CI)- MAA868 30 mg
    Statistical analysis description
    % Difference vs Enoxaparin (95% CI)
    Comparison groups
    Enoxaparin 40 mg mITT v MAA868 30 mg mITT
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0843
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 between treatment differences
    Point estimate
    -9.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.41
         upper limit
    		 1.09
    Statistical analysis title
    		 % Difference vs Enoxaparin(95% CI) - MAA868 75 mg
    Comparison groups
    MAA868 75 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 between-treatment differences
    Point estimate
    -16.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.95
         upper limit
    		 -7.63
    Statistical analysis title
    		 % Difference vs Enoxaparin(95% CI)- MAA868 150 mg
    Comparison groups
    MAA868 150 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 between-treatment differences
    Point estimate
    -17.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.72
         upper limit
    		 -8.81
    Statistical analysis title
    		 % Difference doses combined vs Enoxaparin (95% CI)
    Statistical analysis description
    % Difference (MAA868 150mg and 75mg doses combined) vs Enoxaparin (95% CI)
    Comparison groups
    MAA868 75 mg mITT v MAA868 150 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 between-treatment differences
    Point estimate
    -17.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.83
         upper limit
    		 -8.69

    Secondary: Secondary efficacy endpoint through Day 30 and 110.

    		 Close Top of page
    End point title
    		 Secondary efficacy endpoint through Day 30 and 110.
    End point description
    Secondary efficacy endpoint is the proportion of patients with confirmed composite endpoint of adjudicated asymptomatic DVT, symptomatic DVT, fatal or non-fatal PE, or unexplained death for which PE could not be ruled out during treatment through Days 30 and 110.
    End point type
    Secondary
    End point timeframe
    through Days 30 and 110
    End point values
    		 MAA868 30 mg mITT MAA868 75 mg mITT MAA868 150 mg mITT Enoxaparin 40 mg mITT
    Number of subjects analysed
    102
    99
    98
    101
    Units: number
    13
    5
    4
    22
    Statistical analysis title
    		 % Difference vs Enoxaparin (95% CI)- MAA868 30 mg
    Comparison groups
    MAA868 30 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0843
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 between-treatment differences
    Point estimate
    -9.16
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -19.41
         upper limit
    		 1.09
    Statistical analysis title
    		 % Difference vs Enoxaparin (95% CI)- MAA868 75 mg
    Comparison groups
    MAA868 75 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0006
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 between-treatment differences
    Point estimate
    -16.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.95
         upper limit
    		 -7.63
    Statistical analysis title
    		 % Difference vs Enoxaparin(95% CI)- MAA868 150 mg
    Comparison groups
    MAA868 150 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.0002
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 between-treatment differences
    Point estimate
    -17.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -26.72
         upper limit
    		 -8.81
    Statistical analysis title
    		 % Difference doses combined vs Enoxaparin (95% CI)
    Statistical analysis description
    % Difference (MAA868 150mg and 75mg doses combined) vs Enoxaparin (95% CI)
    Comparison groups
    Enoxaparin 40 mg mITT v MAA868 150 mg mITT v MAA868 75 mg mITT
    Number of subjects included in analysis
    298
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.0001
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 between-treatment differences
    Point estimate
    -17.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -25.83
         upper limit
    		 -8.69

    Secondary: Secondary: composite endpoint of major bleeding and CRNM bleeding

    		 Close Top of page
    End point title
    		 Secondary: composite endpoint of major bleeding and CRNM bleeding
    End point description
    Occurrence of confirmed composite endpoint of major bleeding and CRNM bleeding events through Days 10 and 30
    End point type
    Secondary
    End point timeframe
    Through Days 10 and 30
    End point values
    		 MAA868 30 mg Safety MAA868 75 mg Safety MAA868 150 mg Safety Enoxaparin 40 mg Safety
    Number of subjects analysed
    102
    104
    99
    104
    Units: number
    2
    2
    0
    0
    Statistical analysis title
    		 % Difference vs Enoxaparin - MAA868 30 mg
    Statistical analysis description
    % Difference vs Enoxaparin (95% CI) - MAA868 30 mg i.v.
    Comparison groups
    MAA868 30 mg Safety v Enoxaparin 40 mg Safety
    Number of subjects included in analysis
    206
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1602
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 % Difference
    Point estimate
    1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.74
         upper limit
    		 4.6
    Statistical analysis title
    		 % Difference vs Enoxaparin - MAA868 75 mg
    Statistical analysis description
    % Difference vs Enoxaparin - MAA868 75 mg iv
    Comparison groups
    MAA868 75 mg Safety v Enoxaparin 40 mg Safety
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.1617
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 % Difference
    Point estimate
    1.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -0.72
         upper limit
    		 4.53

    Other pre-specified: Exploratory efficacy endpoint : proportion of patients with symptomatic venous thromboembolism through the Day 110/EoS visit

    		 Close Top of page
    End point title
    		 Exploratory efficacy endpoint : proportion of patients with symptomatic venous thromboembolism through the Day 110/EoS visit
    End point description
    The exploratory efficacy endpoint is the proportion of patients with symptomatic venous thromboembolism (symptomatic deep vein thrombosis and symptomatic pulmonary embolism) through the Day 110/EoS visit
    End point type
    Other pre-specified
    End point timeframe
    Through the Day 110/EoS visit
    End point values
    		 MAA868 30 mg mITT MAA868 75 mg mITT MAA868 150 mg mITT Enoxaparin 40 mg mITT
    Number of subjects analysed
    102
    99
    98
    101
    Units: percentages
    0
    0
    0
    1
    Statistical analysis title
    		 % Difference vs Enoxaparin (95% CI) - MAA868 30 mg
    Comparison groups
    MAA868 30 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3211
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 proportion of patients
    Point estimate
    -0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.9
         upper limit
    		 0.94
    Statistical analysis title
    		 % Difference vs Enoxaparin (95% CI) - MAA868 75 mg
    Comparison groups
    MAA868 75 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    200
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.325
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 proportion of patients
    Point estimate
    -0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 0.94
    Statistical analysis title
    		 % Difference vs Enoxaparin (95% CI)- MAA868 150 mg
    Comparison groups
    MAA868 150 mg mITT v Enoxaparin 40 mg mITT
    Number of subjects included in analysis
    199
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.3289
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 proportion of patients
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 0.94
    Statistical analysis title
    		 % Difference doses combined vs Enoxaparin
    Statistical analysis description
    % Difference (MAA868 150mg and 75mg doses combined) vs Enoxaparin (95% CI)
    Comparison groups
    MAA868 150 mg mITT v MAA868 75 mg mITT
    Number of subjects included in analysis
    197
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.1657
    Method
    		 Cochran-Mantel-Haenszel
    Parameter type
    		 proportion of patients
    Point estimate
    -0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -2.91
         upper limit
    		 0.94

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    Duration of study
    Adverse event reporting additional description
    A TEAE was defined as an adverse event that started during or after the start of the infusion or started prior to the start of the infusion and increased in severity after the start of the infusion.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.0
    Reporting groups
    Reporting group title
    MAA868 30 mg Safety
    Reporting group description
    		 MAA868 30 mg i.v.

    Reporting group title
    MAA868 75 mg Safety
    Reporting group description
    		 MAA868 75 mg i.v.

    Reporting group title
    MAA868 150 mg Safety
    Reporting group description
    		 MAA868 150 mg i.v.

    Reporting group title
    Enoxaparin 40 mg Safety
    Reporting group description
    		 Enoxaparin 40 mg s.c.

    Serious adverse events
    		 MAA868 30 mg Safety MAA868 75 mg Safety MAA868 150 mg Safety Enoxaparin 40 mg Safety
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 102 (0.98%)
    3 / 104 (2.88%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    Gastrointestinal disorders
    Ileus
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian cyst torsion
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Infections and infestations
    Medical device site joint infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Corona virus infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Wound infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 MAA868 30 mg Safety MAA868 75 mg Safety MAA868 150 mg Safety Enoxaparin 40 mg Safety
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    15 / 102 (14.71%)
    16 / 104 (15.38%)
    15 / 99 (15.15%)
    13 / 104 (12.50%)
    Vascular disorders
    Haematoma
         subjects affected / exposed
    0 / 102 (0.00%)
    2 / 104 (1.92%)
    2 / 99 (2.02%)
    2 / 104 (1.92%)
         occurrences all number
    0
    2
    2
    2
    Deep vein thrombosis
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    0
    0
    1
    Peripheral venous disease
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    0
    1
    0
    General disorders and administration site conditions
    Oedema
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    1 / 99 (1.01%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    1
    1
    Asthenia
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    0
    0
    1
    Chest pain
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Pyrexia
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Reproductive system and breast disorders
    Ovarian cyst torsion
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Investigations
    Liver function test abnormal
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    2 / 99 (2.02%)
    2 / 104 (1.92%)
         occurrences all number
    0
    0
    2
    2
    Haemoglobin decreased
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    1 / 104 (0.96%)
         occurrences all number
    0
    0
    1
    1
    Alanine aminotransferase increased
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Injury, poisoning and procedural complications
    Contusion
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    2 / 104 (1.92%)
         occurrences all number
    1
    0
    0
    2
    Post procedural oedema
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    1
    0
    1
    Ligament injury
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Post procedural inflammation
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    0
    0
    1
    Post procedural swelling
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Procedural haemorrhage
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Seroma
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Spinal compression fracture
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    0
    0
    1
    Cardiac disorders
    Atrial fibrillation
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 104 (0.96%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    1
    1
    1
    0
    Cardiac failure chronic
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Sinus node dysfunction
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    2 / 102 (1.96%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    2
    0
    0
    0
    Blood and lymphatic system disorders
    Spontaneous haematoma
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    0
    0
    1
    Ear and labyrinth disorders
    Vertigo
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    1
    0
    0
    Diarrhoea
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Gastric ulcer
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Ileus
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Hepatobiliary disorders
    Cholecystitis chronic
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Hepatitis toxic
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Alopecia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Endocrine disorders
    Hyperthyroidism
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Musculoskeletal and connective tissue disorders
    Ligament disorder
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Infections and infestations
    Corona virus infection
         subjects affected / exposed
    2 / 102 (1.96%)
    1 / 104 (0.96%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    2
    1
    1
    0
    Laryngitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    1
    0
    Medical device site joint infection
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Bronchitis
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Pneumonia
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Urinary tract infection
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    1 / 104 (0.96%)
         occurrences all number
    0
    0
    0
    1
    Vulvovaginal candidiasis
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    0
    0
    Wound infection
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0
    Metabolism and nutrition disorders
    Glucose tolerance impaired
         subjects affected / exposed
    1 / 102 (0.98%)
    1 / 104 (0.96%)
    2 / 99 (2.02%)
    2 / 104 (1.92%)
         occurrences all number
    1
    1
    2
    2
    Decreased appetite
         subjects affected / exposed
    0 / 102 (0.00%)
    1 / 104 (0.96%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    1
    1
    0
    Cell death
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Aspartate aminotransferase increased
         subjects affected / exposed
    0 / 102 (0.00%)
    0 / 104 (0.00%)
    1 / 99 (1.01%)
    0 / 104 (0.00%)
         occurrences all number
    0
    0
    1
    0
    Platelet count decreased
         subjects affected / exposed
    1 / 102 (0.98%)
    0 / 104 (0.00%)
    0 / 99 (0.00%)
    0 / 104 (0.00%)
         occurrences all number
    1
    0
    0
    0

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    23 Jul 2020
    Amendment Rationale This protocol was amended to minimize the impact of COVID-19 on the study and to incorporate changes requested by Health Authorities. These changes are intended to reduce the burden on patients participating in the study and to provide clarification and guidance to sites in response to restrictions that may be put in place due to COVID-19. In addition, the Sponsor is using this opportunity to incorporate changes to the protocol requested by the Latvian Health Authority.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Fri Apr 26 22:37:29 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA