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   43889   clinical trials with a EudraCT protocol, of which   7298   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 Phase 4, Open Label, Safety and Efficacy Study of Fabrazyme® (Agalsidase Beta) as Enzyme Replacement Therapy in Chinese Subjects With Fabry Disease

    Summary
    EudraCT number
    		 2023-000624-11
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    09 Mar 2023

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Sep 2023
    First version publication date
    14 Sep 2023
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    LPS16583
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT05054387
    WHO universal trial number (UTN)
    		 U1111-1255-4881
    Sponsors
    Sponsor organisation name
    Sanofi B.V.
    Sponsor organisation address
    Paasheuvelweg 25, BP Amsterdam, Netherlands, 1105
    Public contact
    Trial Transparency Team, Sanofi Recherche et Développement, Contact-US@sanofi.com
    Scientific contact
    Trial Transparency Team, Sanofi Recherche et Développement, Contact-US@sanofi.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?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    27 Mar 2023
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Mar 2023
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the safety and tolerability of Fabrazyme in Chinese fabry disease subjects.
    Protection of trial subjects
    The study was conducted by investigators experienced in the treatment of adults and paediatric subjects. The parent(s) or guardian(s) as well as the children were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time. In addition to the consent form for the parent(s)/guardian(s), an assent form in child-appropriate language was provided and explained to the child. Repeated invasive procedures were minimised. The number of blood samples as well as the amount of blood drawn were adjusted according to age and weight. A topical anesthesia may have been used to minimise distress and discomfort. Adult subjects were fully informed of all pertinent aspects of the clinical trial as well as the possibility to discontinue at any time in language and terms appropriate for the subject and considering the local culture. During the course of the trial, subjects were provided with individual subject cards indicating the nature of the trial the subject is participating, contact details and any information needed in the event of a medical emergency. Collected personal data and human biological samples were processed in compliance with the Sanofi-Aventis Group Personal Data Protection Charter ensuring that the Group abides by the laws governing personal data protection in force in all countries in which it operates.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    13 Oct 2021
    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
    China: 22
    Worldwide total number of subjects
    22
    EEA total number of subjects
    0
    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)
    2
    Adolescents (12-17 years)
    2
    Adults (18-64 years)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at 6 centers in China between 13-October-2021 to 09-March-2023.

    Pre-assignment
    Screening details
    		 A total of 22 subjects were enrolled and treated in the study.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Fabrazyme: All Subjects
    Arm description
    		 Subjects received agalsidase beta (Fabrazyme) intravenous (IV) infusion at a dose of 1 milligram per kilogram (mg/kg) body weight, every other week (Q2W) for up to Week 48.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Agalsidase beta
    Investigational medicinal product code
    GZ419828
    Other name
    Fabrazyme
    Pharmaceutical forms
    Powder for solution for infusion
    Routes of administration
    Intravenous bolus use
    Dosage and administration details
    Agalsidase beta IV infusion, 1 mg/kg body weight, Q2W.

    Number of subjects in period 1
    		Fabrazyme: All Subjects
    Started
    22
    Completed
    22

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall Period
    Reporting group description
    		 Subjects received agalsidase beta (Fabrazyme) IV infusion at a dose of 1 mg/kg body weight, Q2W for up to Week 48.

    Reporting group values
    		 Overall Period Total
    Number of subjects
    		 22 22
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 29.0 ± 13.5 -
    Gender categorical
    Units: Subjects
        Female
    		 4 4
        Male
    		 18 18

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Fabrazyme: All Subjects
    Reporting group description
    		 Subjects received agalsidase beta (Fabrazyme) intravenous (IV) infusion at a dose of 1 milligram per kilogram (mg/kg) body weight, every other week (Q2W) for up to Week 48.

    Primary: Number of Subjects with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs)

    		 Close Top of page
    End point title
    		 Number of Subjects with Treatment-emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), and Adverse Events of Special Interest (AESIs) [1]
    End point description
    Adverse Event (AE) was defined as any untoward medical occurrence in subject who received study drug and did not necessarily had a causal relationship with treatment. TEAEs were defined as AEs that developed, worsened/became serious during treatment-emergent period (time from 1st dose of study drug to the last dose of study drug + 14 days). SAE was any AE that at any dose: resulted in death, was life-threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was medically important event or was suspected transmission of any infectious agent via authorised medicinal product. AESI was any AE of scientific and medical concern specific to the study for which ongoing monitoring and immediate notification to the Sponsor was required. Analysis performed on exposed population which included all enrolled subjects who had taken at least one dose of study drug.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to 14 days after last dose of study drug (i.e., up to Week 50)
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: Subjects
        TEAEs
    22
        SAEs
    2
        AESIs
    8
    No statistical analyses for this end point

    Primary: Number of Subjects with Infusion Associated Reactions (IARs)

    		 Close Top of page
    End point title
    		 Number of Subjects with Infusion Associated Reactions (IARs) [2]
    End point description
    Adverse Event was defined as any untoward medical occurrence in subject who received study drug and did not necessarily had a causal relationship with treatment. Infusion Associated Reactions (IARs) were the AEs that occurred during the infusion or within 24 hours after the start of infusion and was considered as related or possibly related to the study intervention by the Investigator or the Sponsor. An event occurring >=24 hours after the start of an infusion may be deemed an IAR if a delayed reaction was considered possible by the Investigator or the Sponsor. Analysis was performed on exposed population.
    End point type
    Primary
    End point timeframe
    From first dose of study drug up to Week 48
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: As the endpoint was descriptive in nature, no statistical analysis was provided.
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: Subjects
    8
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Plasma Lyso-GL-3 at Weeks 6, 12, 24 and 48

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in Plasma Lyso-GL-3 at Weeks 6, 12, 24 and 48
    End point description
    Change in Plasma globotriaosylsphingosine-3 (Lyso-GL-3) values in blood was evaluated by measuring level of total plasma lyso-GL-3. Blood samples were collected at Baseline, Week 6, Week 12, Week 24 and Week 48 to evaluate the absolute change in plasma lyso-GL-3 from Baseline. Analysis performed on exposed population. Here ‘n’ refers to the number of subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6, 12, 24 and 48
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: microgram(s) per litre (mcg/L)
    arithmetic mean (standard deviation)
        Week 6 (n=16)
    -45.758 ± 29.607
        Week 12 (n=14)
    -37.275 ± 31.187
        Week 24 (n=18)
    -43.241 ± 32.193
        Week 48 (n=20)
    -44.230 ± 32.934
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Plasma Lyso-GL-3 at Weeks 6, 12, 24 and 48

    		 Close Top of page
    End point title
    		 Percent Change From Baseline in Plasma Lyso-GL-3 at Weeks 6, 12, 24 and 48
    End point description
    Change in Plasma Lyso-GL-3 values in blood was evaluated by measuring level of total plasma lyso-GL-3. Blood samples were collected at Baseline, Week 6, Week 12, Week 24 and Week 48 to evaluate the percent change in plasma lyso-GL-3 from Baseline. Percent change from Baseline was calculated as: Percent change = (post-baseline value-Baseline value)/Baseline value *100%. Analysis performed on exposed population. Here ‘n’ refers to the number of subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6, 12, 24 and 48
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: percent change
    arithmetic mean (standard deviation)
        Week 6 (n=16)
    -64.881 ± 12.684
        Week 12 (n=14)
    -58.837 ± 20.181
        Week 24 (n=18)
    -61.745 ± 18.781
        Week 48 (n=20)
    -60.320 ± 21.957
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Plasma GL-3 at Weeks 6, 12, 24 and 48

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in Plasma GL-3 at Weeks 6, 12, 24 and 48
    End point description
    Change in plasma Globotriaosylceramide -3 (GL-3) values in blood was evaluated by measuring level of total plasma GL-3. Blood samples were collected at Baseline, Week 6, Week 12, Week 24 and Week 48 to evaluate the absolute change in plasma GL-3 from Baseline. Analysis was performed on exposed population. Here ‘n’ refers to the number of subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6, 12, 24 and 48
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: milligram(s) per litre (mg/L)
    arithmetic mean (standard deviation)
        Week 6 (n=16)
    -3.289 ± 1.922
        Week 12 (n=14)
    -2.693 ± 1.999
        Week 24 (n=18)
    -3.257 ± 2.173
        Week 48 (n=20)
    -2.921 ± 2.442
    No statistical analyses for this end point

    Secondary: Percent Change From Baseline in Plasma GL-3 at Weeks 6, 12, 24 and 48

    		 Close Top of page
    End point title
    		 Percent Change From Baseline in Plasma GL-3 at Weeks 6, 12, 24 and 48
    End point description
    Change in plasma GL-3 values in blood was evaluated by measuring level of total plasma GL-3. Blood samples were collected at Baseline, Week 6, Week 12, Week 24 and Week 48 to evaluate the absolute change in plasma GL-3 from Baseline. Percent change from Baseline was calculated as Percent change = (post-Baseline value-Baseline value)/Baseline value *100 %. Analysis was performed on exposed population. Here ‘n’ refers to the number of subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 6, 12, 24 and 48
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: percent change
    arithmetic mean (standard deviation)
        Week 6 (n=16)
    -41.932 ± 14.899
        Week 12 (n=14)
    -36.404 ± 19.205
        Week 24 (n=18)
    -41.458 ± 16.807
        Week 48 (n=20)
    -34.577 ± 27.356
    No statistical analyses for this end point

    Secondary: Number of Subjects With Abnormal Plasma GL-3 Values at Weeks 6, 12, 24 and 48

    		 Close Top of page
    End point title
    		 Number of Subjects With Abnormal Plasma GL-3 Values at Weeks 6, 12, 24 and 48
    End point description
    Number of subjects with abnormal plasma GL-3 values per the central lab reference range were presented in this endpoint. Blood samples for the estimation of plasma GL-3 values were collected at Week 6, 12, 24 and 48. Analysis was performed on exposed population.
    End point type
    Secondary
    End point timeframe
    At Week 6, 12, 24 and 48
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: Subjects
        Week 6
    13
        Week 12
    8
        Week 24
    12
        Week 48
    13
    No statistical analyses for this end point

    Secondary: Number of Subjects with Change From Baseline in Fabry Disease Symptoms Assessment at Week 24 and Week 48

    		 Close Top of page
    End point title
    		 Number of Subjects with Change From Baseline in Fabry Disease Symptoms Assessment at Week 24 and Week 48
    End point description
    Fabry disease symptoms (angiokeratoma, sweating, chronic abdominal pain, level of activity, exercise tolerance and heat tolerance, headache, tinnitus) were assessed at Baseline, Week 24 and Week 48 to determine the change in the symptoms from Baseline at the specified timepoints. The disease symptoms were assessed as improved, worsened or same. Analysis was performed on exposed population. Here ‘n’ refers to the number of subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    From Baseline up to Week 24 and Week 48
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: Subjects
        Week 24 – Improved (n=22)
    8
        Week 24 – Worsen (n=22)
    0
        Week 24 - Same (n=22)
    14
        Week 48 - Improved (n=21)
    13
        Week 48 – Worsen (n=21)
    0
        Week 48 – Same (n=21)
    8
    No statistical analyses for this end point

    Secondary: Absolute Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Weeks 12, 24, 36 and 48

    		 Close Top of page
    End point title
    		 Absolute Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at Weeks 12, 24, 36 and 48
    End point description
    Estimated Glomerular Filtration Rate (eGFR) was estimated from serum creatinine using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula for adults and from serum creatinine and height using Bedside Schwartz Formula for children (less than equal to 8 years of age to less than 18 years of age). Analysis was performed on exposed population. Here ‘n’ refers to the number of subjects with available data for each specified category.
    End point type
    Secondary
    End point timeframe
    Baseline, Week 12, 24, 36 and 48
    End point values
    		 Fabrazyme: All Subjects
    Number of subjects analysed
    22
    Units: millilitre/minute/1.73 metre square
    arithmetic mean (standard deviation)
        Week 12 (n=14)
    1.5 ± 10.5
        Week 24 (n=18)
    -0.1 ± 17.8
        Week 36 (n=15)
    0.4 ± 16.1
        Week 48 (n=20)
    0.0 ± 12.4
    No statistical analyses for this end point

    Adverse events

    		 Close Top of page
    Adverse events information
    Timeframe for reporting adverse events
    From first dose of study drug up to 14 days after last dose of study drug (i.e., up to Week 50)
    Adverse event reporting additional description
    Analysis was performed on exposed population.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    Fabrazyme
    Reporting group description
    		 Subjects received agalsidase beta (Fabrazyme), IV infusion at a dose of 1 mg/kg body weight, Q2W for up to Week 48.

    Serious adverse events
    		 Fabrazyme
    Total subjects affected by serious adverse events
         subjects affected / exposed
    2 / 22 (9.09%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Nervous system disorders
    Tension Headache
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Renal and urinary disorders
    End Stage Renal Disease
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Fabrazyme
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    22 / 22 (100.00%)
    General disorders and administration site conditions
    Pyrexia
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    4
    Oedema Peripheral
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Non-Cardiac Chest Pain
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Feeling Hot
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    Chills
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    Chest Discomfort
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Asthenia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Epistaxis
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Cough
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Psychiatric disorders
    Depression
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Investigations
    C-Reactive Protein Increased
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Red Blood Cell Sedimentation Rate Increased
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Weight Decreased
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Weight Increased
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    3
    Headache
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Blood and lymphatic system disorders
    Nephrogenic Anaemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Eye disorders
    Vision Blurred
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    2
    Gastrointestinal disorders
    Vomiting
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    2
    Toothache
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Nausea
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    4
    Diarrhoea
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Constipation
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Hepatobiliary disorders
    Cholelithiasis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Skin and subcutaneous tissue disorders
    Rash
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Pruritus
         subjects affected / exposed
    3 / 22 (13.64%)
         occurrences all number
    5
    Renal and urinary disorders
    Renal Hypertension
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Endocrine disorders
    Hyperparathyroidism Secondary
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Musculoskeletal and connective tissue disorders
    Pain In Extremity
         subjects affected / exposed
    2 / 22 (9.09%)
         occurrences all number
    3
    Myalgia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Chronic Kidney Disease-Mineral And Bone Disorder
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Ankylosing Spondylitis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Infections and infestations
    Covid-19
         subjects affected / exposed
    14 / 22 (63.64%)
         occurrences all number
    14
    Cholecystitis Infective
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Gastroenteritis
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Urinary Tract Infection
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Upper Respiratory Tract Infection
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    7
    Influenza
         subjects affected / exposed
    4 / 22 (18.18%)
         occurrences all number
    5
    Otitis Media
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Metabolism and nutrition disorders
    Hypocalcaemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Hyperphosphataemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Hyperhomocysteinaemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Hypoproteinaemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1
    Hyperuricaemia
         subjects affected / exposed
    1 / 22 (4.55%)
         occurrences all number
    1

    More information

    		 Close Top of page

    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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-Sun May 26 10:03:38 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA