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    Clinical Trial Results:
    A RANDOMISED, MULTICENTRE, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY ON THE EFFICACY AND SAFETY OF A THERAPEUTIC STRATEGY OF POST PARTUM HAEMORRHAGE COMPARING EARLY ADMINISTRATION OF HUMAN FIBRINOGEN VERSUS PLACEBO IN PATIENTS TREATED WITH INTRAVENOUS PROSTAGLANDINS FOLLOWING VAGINAL DELIVERY.

    Summary
    EudraCT number
    		 2013-002484-26
    Trial protocol
    		 FR  
    Global end of trial date
    06 Aug 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Jun 2020
    First version publication date
    18 Jun 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FIDEL
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02155725
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    LFB Biomédicaments
    Sponsor organisation address
    3, Avenue des tropiques, LES ULIS, France, 91940
    Public contact
    Medical Director france, LFB Biomédicaments, 33 169827229, zitounis@lfb.fr
    Scientific contact
    Medical Director france, LFB Biomédicaments, 33 169827229, zitounis@lfb.fr
    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
    20 May 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Aug 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of the study is to assess the benefits of a therapeutic strategy that associates an early administration of human fibrinogen concentrate in the management of PPH on the reduction of bleeding after the initiation of prostaglandins intravenous infusion.
    Protection of trial subjects
    This study was conducted in compliance with good clinical practice (GCP) as described in the International Conference on Harmonisation (ICH) document “Guidance for Industry-E6 Good Clinical Practice: Consolidated Guidance”. These practices were consistent with the principles stated in the Declaration of Helsinki. All other applicable regulations were followed. Due to the context of emergency, consent was obtained after a concise information from the patient or a member of her family or a reliable person, depending on the patient's level of consciousness. In all cases, as soon as the patient regained competence, she received full information about the study and a post-inclusion consent to continue the study was requested.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    10 Apr 2014
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    France: 448
    Worldwide total number of subjects
    448
    EEA total number of subjects
    448
    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)
    448
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Between 10 April 2014 and 20 June 2018, 448 patients from 30 sites signed an informed consent.

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 448
    Number of subjects completed
    		 437

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 treated with another IMP: 1
    Reason: Number of subjects
    		 not treated: 5
    Reason: Number of subjects
    		 no emergency consent signed: 2
    Reason: Number of subjects
    		 no post inclusion consent signed: 1
    Reason: Number of subjects
    		 refused to continue the study: 2
    Period 1
    Period 1 title
    Treatment period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Clottafact group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clottafact
    Investigational medicinal product code
    Other name
    Fibrinogen concentrate
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Fibrinogen: 3g; 2 vials of 1.5g/100 mL, each vial of powder will be reconstituted with 100 mL of sterile water for injection. Route of administration: IV administration with a flow rate ≤ 20 mL/min

    Arm title
    		 Placebo group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Placebo: 2 vials of 100 mL, each vial of powder will be reconstituted with 100 mL of sterile water for injection. Route of administration: IV administration with a flow rate ≤ 20 mL/min

    Number of subjects in period 1 [1]
    		Clottafact group Placebo group
    Started
    224
    213
    Completed
    224
    213
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: 448 patients from 30 sites signed an informed consent but only 437 patients included after the pre-assigment period.
    Period 2
    Period 2 title
    Follow-up period
    Is this the baseline period?
    		 No
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator, Monitor, Data analyst
    Blinding implementation details
    During this follow-up period, no new randomisation for the patients, but the blind is maintained.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Clottafact group
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    Clottafact
    Investigational medicinal product code
    Other name
    Fibrinogen concentrate
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    No injection during this period.

    Arm title
    		 Placebo group
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    No injection during this period

    Number of subjects in period 2
    		Clottafact group Placebo group
    Started
    224
    213
    Completed
    207
    202
    Not completed
    17
    11
         Patient refusal to continue
    3
    -
         Consent withdrawn by subject
    -
    5
         Last visit not done
    10
    4
         Protocol deviation
    4
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Clottafact group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Reporting group values
    		 Clottafact group Placebo group Total
    Number of subjects
    		 224 213 437
    Age categorical
    Units: Subjects
        Adults (18-64 years)
    		 224 213 437
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.5 ( 5.6 ) 30.3 ( 5.4 ) -
    Gender categorical
    Units: Subjects
        Female
    		 224 213 437
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Clottafact group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -
    Reporting group title
    Clottafact group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Subject analysis set title
    PP Set Clottafact
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients with no missing data for the primary criterion.

    Subject analysis set title
    PP Set Placebo
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Patients with no missing data for the primary criterion.

    Subject analysis set title
    ITT Set Clottafact
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients treated with Clottafact.

    Subject analysis set title
    ITT Set Placebo
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    All patients treated with Placebo.

    Subject analysis set title
    FAS Set Clottafact
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients treated with Clottafact of the ITT Set with no missing data for the primary criteria.

    Subject analysis set title
    FAS Set Placebo
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Patients treated with Placebo of the ITT Set with no missing data for the primary criteria.

    Primary: Failure rate of PPH management

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    End point title
    		 Failure rate of PPH management
    End point description
    The primary efficacy variable is a binary (Failure versus Success) composite endpoint. Failure is defined when a patient: - loses at least 4 g/dL of Hb compared to the reference Hb level , AND/OR - requires the transfusion of at least 2 units of packed RBCs.
    End point type
    Primary
    End point timeframe
    Evaluation of the two criteria that form the primary endpoint within the 48 h following the administration of IMP.
    End point values
    		 PP Set Clottafact PP Set Placebo FAS Set Clottafact FAS Set Placebo
    Number of subjects analysed
    195 [1]
    193 [2]
    220 [3]
    210 [4]
    Units: number of patients with failure
    75
    80
    88
    89
    Notes
    [1] - 38,5 % of patients in failure
    [2] - 41,5 % of patients in failure
    [3] - 40,0 % of patients in failure
    [4] - 42,4 % of patients in failure
    Statistical analysis title
    		 Failure rate
    Statistical analysis description
    Logistic regression adjusting for baseline fibrinogen level and centre.
    Comparison groups
    FAS Set Clottafact v FAS Set Placebo
    Number of subjects included in analysis
    430
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9563
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.9889
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6633
         upper limit
    		 1.4744

    Secondary: Patients with at least administration of 2 units of RBCs

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    End point title
    		 Patients with at least administration of 2 units of RBCs
    End point description
    Considering failure as the fact of requiring at least 2 units of RBCs.
    End point type
    Secondary
    End point timeframe
    from H0 to Day 2
    End point values
    		 FAS Set Clottafact FAS Set Placebo
    Number of subjects analysed
    220 [5]
    210 [6]
    Units: number of patients
    51
    52
    Notes
    [5] - 23,4 % of patients with administration of at least 2 RBCs.
    [6] - 25,0 % of patients with administration of at least 2 RBCs.
    Statistical analysis title
    		 Failure on the adminidtration of RBCs
    Statistical analysis description
    Failure on individual component of the primary endpoint defined as administration of 2 units of RBCs
    Comparison groups
    FAS Set Clottafact v FAS Set Placebo
    Number of subjects included in analysis
    430
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9786
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.0064
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6321
         upper limit
    		 1.6022

    Secondary: Patients with lost of at least 4 g/dL of Hb

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    End point title
    		 Patients with lost of at least 4 g/dL of Hb
    End point description
    Considering failure as the fact of having lost at least 4 g/dL of Hb.
    End point type
    Secondary
    End point timeframe
    From reference value to Day 2
    End point values
    		 FAS Set Clottafact FAS Set Placebo
    Number of subjects analysed
    220 [7]
    210 [8]
    Units: number of patients
    42
    41
    Notes
    [7] - 19,1 % of patients with lost of at least 4 g/dL of Hb.
    [8] - 19,5 % of patients with lost of at least 4 g/dL of Hb.
    Statistical analysis title
    		 Failure on the loss of Hb
    Statistical analysis description
    Failure on individual component of the primary endpoint defined as a loss of at least 4 g/dL of Hb
    Comparison groups
    FAS Set Clottafact v FAS Set Placebo
    Number of subjects included in analysis
    430
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 = 0.9474
    Method
    		 Regression, Logistic
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    1.0169
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6177
         upper limit
    		 1.6741

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The adverse events are reported from the inclusion to the end of the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Clottafact group
    Reporting group description
    		 -

    Reporting group title
    Placebo group
    Reporting group description
    		 -

    Serious adverse events
    		 Clottafact group Placebo group
    Total subjects affected by serious adverse events
         subjects affected / exposed
    10 / 224 (4.46%)
    10 / 213 (4.69%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Investigations
    Blood alkaline phosphatase increased
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure ambulatory increased
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood uric acid increased
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Vascular disorders
    Aneurysm
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Blood pressure inadequately controlled
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hypotension
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Shock haemorrhagic
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Thrombosis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Venous thrombosis limb
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Nervous system disorders
    Headache
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    HELLP syndrome
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Postpartum haemorrhage
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Retained placenta or membranes
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    General disorders and administration site conditions
    Discomfort
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Oedema peripheral
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyrexia
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Broad ligament haematoma
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metrorrhagia
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine haematoma
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine necrosis
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Uterine rupture
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Hepatobiliary disorders
    Acute fatty liver of pregnancy
         subjects affected / exposed
    0 / 224 (0.00%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Respiratory, thoracic and mediastinal disorders
    Acute pulmonary oedema
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Psychiatric disorders
    Psychological trauma
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Amniotic cavity infection
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Endometritis decidual
         subjects affected / exposed
    1 / 224 (0.45%)
    1 / 213 (0.47%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis acute
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Metabolism and nutrition disorders
    Hyperglycaemia
         subjects affected / exposed
    1 / 224 (0.45%)
    0 / 213 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Clottafact group Placebo group
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    95 / 224 (42.41%)
    106 / 213 (49.77%)
    Vascular disorders
    Hypertension
         subjects affected / exposed
    3 / 224 (1.34%)
    6 / 213 (2.82%)
         occurrences all number
    3
    6
    Hypotension
         subjects affected / exposed
    5 / 224 (2.23%)
    4 / 213 (1.88%)
         occurrences all number
    5
    4
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    2 / 224 (0.89%)
    3 / 213 (1.41%)
         occurrences all number
    3
    3
    Headache
         subjects affected / exposed
    5 / 224 (2.23%)
    7 / 213 (3.29%)
         occurrences all number
    6
    8
    General disorders and administration site conditions
    Hyperthermia
         subjects affected / exposed
    2 / 224 (0.89%)
    5 / 213 (2.35%)
         occurrences all number
    2
    5
    Influenza like illness
         subjects affected / exposed
    0 / 224 (0.00%)
    3 / 213 (1.41%)
         occurrences all number
    0
    3
    Oedema peripheral
         subjects affected / exposed
    4 / 224 (1.79%)
    6 / 213 (2.82%)
         occurrences all number
    4
    6
    Pyrexia
         subjects affected / exposed
    11 / 224 (4.91%)
    12 / 213 (5.63%)
         occurrences all number
    11
    12
    Malaise
         subjects affected / exposed
    2 / 224 (0.89%)
    4 / 213 (1.88%)
         occurrences all number
    2
    4
    Gastrointestinal disorders
    Abdominal pain
         subjects affected / exposed
    4 / 224 (1.79%)
    1 / 213 (0.47%)
         occurrences all number
    4
    1
    Constipation
         subjects affected / exposed
    9 / 224 (4.02%)
    4 / 213 (1.88%)
         occurrences all number
    9
    4
    Haemorrhoids
         subjects affected / exposed
    21 / 224 (9.38%)
    29 / 213 (13.62%)
         occurrences all number
    21
    29
    Nausea
         subjects affected / exposed
    0 / 224 (0.00%)
    4 / 213 (1.88%)
         occurrences all number
    0
    4
    Vomiting
         subjects affected / exposed
    1 / 224 (0.45%)
    4 / 213 (1.88%)
         occurrences all number
    1
    4
    Reproductive system and breast disorders
    Metrorrhagia
         subjects affected / exposed
    6 / 224 (2.68%)
    3 / 213 (1.41%)
         occurrences all number
    6
    3
    Nipple disorder
         subjects affected / exposed
    0 / 224 (0.00%)
    4 / 213 (1.88%)
         occurrences all number
    0
    4
    Oedema genital
         subjects affected / exposed
    2 / 224 (0.89%)
    5 / 213 (2.35%)
         occurrences all number
    2
    5
    Uterine pain
         subjects affected / exposed
    4 / 224 (1.79%)
    0 / 213 (0.00%)
         occurrences all number
    4
    0
    Vulval oedema
         subjects affected / exposed
    0 / 224 (0.00%)
    4 / 213 (1.88%)
         occurrences all number
    0
    4
    Hepatobiliary disorders
    Hepatocellular injury
         subjects affected / exposed
    3 / 224 (1.34%)
    0 / 213 (0.00%)
         occurrences all number
    3
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    3 / 224 (1.34%)
    1 / 213 (0.47%)
         occurrences all number
    3
    1
    Musculoskeletal and connective tissue disorders
    Back pain
         subjects affected / exposed
    3 / 224 (1.34%)
    4 / 213 (1.88%)
         occurrences all number
    3
    4
    Infections and infestations
    Endometritis decidual
         subjects affected / exposed
    4 / 224 (1.79%)
    5 / 213 (2.35%)
         occurrences all number
    4
    5
    Puerperal pyrexia
         subjects affected / exposed
    7 / 224 (3.13%)
    4 / 213 (1.88%)
         occurrences all number
    7
    4
    Urinary tract infection
         subjects affected / exposed
    4 / 224 (1.79%)
    0 / 213 (0.00%)
         occurrences all number
    4
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    10 Feb 2015
    In a purpose to facilitate the emergency procedure, the information sheet and the informed consent have been simplified in terms of both content and form, without modifying the meaning and the purpose of the provided information.
    21 Dec 2017
    The purpose of this amendment was to update the patient information leaflet (emergency and post-inclusion) according to the new version of the Clottafact SPC .
    29 Mar 2018
    The purpose of this amendment is to update the patient information leaflet (emergency and post-inclusion) according to the new version of the Clottafact SPC.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Feb 2018
    Interruption of inclusions due to IMP shortage
    19 Mar 2018

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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    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.

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