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    Summary
    EudraCT Number:2019-001760-30
    Sponsor's Protocol Code Number:CB8025-21845
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2019-06-27
    Trial results View results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2019-001760-30
    A.3Full title of the trial
    A Phase 2, Randomized, Double-Blind, Placebo-Controlled Multiple Center Study to Evaluate the Safety, Tolerability, and Efficacy of Seladelpar Administered for 24 Weeks in Adult Patients with Primary Sclerosing Cholangitis (PSC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The aim of this study is to assess the safety, tolerability and efficacy of seladelpar in subjects with Primary Sclerosing Cholangitis (PSC)
    A.4.1Sponsor's protocol code numberCB8025-21845
    A.5.4Other Identifiers
    Name:IND Number:Number: 142198
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorCymaBay Therapeutics
    B.1.3.4CountryUnited States
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportCymaBay Therapeutics
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCymaBay Therapeutics
    B.5.2Functional name of contact pointJaidyn Nguyen
    B.5.3 Address:
    B.5.3.1Street Address7575 Gateway Boulevard Ste 110
    B.5.3.2Town/ cityNewark
    B.5.3.3Post code94560
    B.5.3.4CountryUnited States
    B.5.4Telephone number+1510 293-8833
    B.5.5Fax number+1510- 293-6853
    B.5.6E-mailjnguyen@cymabay.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSeladelpar
    D.3.2Product code MBX-8025
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSELADELPAR
    D.3.9.1CAS number 928821-40-3
    D.3.9.2Current sponsor codeMBX-8025
    D.3.9.4EV Substance CodeSUB192392
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSeladelpar
    D.3.2Product code MBX-8025
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSELADELPAR
    D.3.9.1CAS number 928821-40-3
    D.3.9.2Current sponsor code MBX-8025
    D.3.9.4EV Substance CodeSUB192392
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameSeladelpar
    D.3.2Product code MBX-8025
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNSELADELPAR
    D.3.9.1CAS number 928821-40-3
    D.3.9.2Current sponsor codeMBX-8025
    D.3.9.4EV Substance CodeSUB192392
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Primary Sclerosing Cholangitis (PSC) is a chronic cholestatic liver disease that is characterized by diffuse inflammation and fibrosis of the bile ducts. The intra and/or extrahepatic bile ducts can be affected with ongoing ductal destruction leading to cholestasis, advanced fibrosis, and cirrhosis. Disease progression will eventually lead to liver failure with its consequent complications such as portal hypertension and increased risk of malignancy, including HCC and cholangiocarcinoma.
    E.1.1.1Medical condition in easily understood language
    Disease of the liver
    E.1.1.2Therapeutic area Diseases [C] - Digestive System Diseases [C06]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level LLT
    E.1.2Classification code 10036732
    E.1.2Term Primary sclerosing cholangitis
    E.1.2System Organ Class 100000004871
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    •Evaluate the treatment effect of seladelpar on relative (%) change in AP in subjects with PSC during the study period
    E.2.2Secondary objectives of the trial
    •Assess the safety and tolerability of seladelpar in subjects with PSC during the study period
    •Evaluate the effect of seladelpar on the absolute and/or relative (%) changes of the following:
    oAlanine aminotransferase (ALT), AP, aspartate aminotransferase (AST), bilirubin (total, direct), and gamma-glutamyl transpeptidase (GGT)
    oTotal cholesterol, HDL-cholesterol, LDL-cholesterol, and triglycerides
    o7-Alpha-hydroxy-4-cholesten-3-one (C4) and serum bile acids
    oHigh-sensitivity C-reactive protein (hs-CRP) and fibrinogen
    oELF Score (total and individual components) and PRO-C3 levels
    •Evaluate changes in pruritus, fatigue, and quality of life (QoL)
    •Assess changes in symptoms associated with Inflammatory Bowel Disease (IBD) during the study period
    •Evaluate the changes in PSC-related symptoms and adverse events
    •Evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of seladelpar in subjects with PSC
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    an optional PK sub-study part of this protocol:
    A minimum of 6 subjects per treatment arm will participate in an optional PK sub-study to assess a complete 24-hour PK profile after a single dose. Samples will be collected at Baseline (pre-dose) and 0.5, 1, 2, 4, 8, 12 and 24 hours after dosing. Additional blood and urine will be collected at specified time points during this time-period to assess additional PD and PK parameters. Subjects will remain in clinic through the 8-hour timepoint and return to clinic for the 12- and 24-hour sample collections. The window for PK sample collection for the Baseline is within 30 minutes of the pre-dose timepoint, ± 5 minutes for the 0.5-hour through the 8-hour samples, and ± 30 minutes for the 12- and 24-hour samples.
    Urine will also be collected over the 24 24-hour period to assess the renal clearance of seladelpar and the primary metabolites.

    informed consent for PK sub-study (optional) will be provided to the patient
    E.3Principal inclusion criteria
    Patients who meet the following criteria may be included in the study:
    1.Males and females who are 18 years of age and older and are able to comprehend instructions and follow the study procedures and are willing to sign an Informed Consent Form (ICF)
    2.Confirmed diagnosis of PSC based on any two of the following three criteria:
    •Historical evidence of an elevated AP > ULN from any prior laboratory result
    •Liver biopsy consistent with PSC
    •Abnormal cholangiography consistent with PSC as measured by MRCP, ERCP, or PTC
    3.Participants must have the following specific additional laboratory parameters measured by the Central Laboratory at Screening:
    •AP > 1.5 × ULN but < 8 × ULN
    •Total bilirubin ≤ 2 × ULN
    •ALT and AST ≤ 5 × ULN
    •eGFR > 60 mL/min/1.73 m2 by modification of diet in renal disease (MDRD) calculation
    •Platelets ≥ 140 × 103/µL
    •INR ≤ 1.3 (in the absence of warfarin or other anticoagulant therapy)
    •Albumin > 3.5 g/dL
    4.Patients taking UDCA will be allowed to enroll if meeting the following criteria:
    •Total daily dose of < 20 mg/kg/day
    •A minimum of 24 weeks of stable treatment
    •Minimum of 12 weeks off treatment prior to Screening if UDCA is recently discontinued
    5.Patients with concomitant IBD may enroll upon meeting the following criteria:
    •A colonoscopy performed within 12 to 18 months (as defined by local guidelines) of consent or during the Screening period, with no evidence of dysplasia
    •No episode of an IBD flare or IBD flare-related bloody diarrhea within24 weeks of Screening and through Day 1
    •Stable regimen of biologic treatments, immunosuppressive, or systemic corticosteroids (≤10 mg/day prednisone or equivalent) for > 12 weeks prior to Screening and through Day 1
    6.Participants with FibroScan values ≤14.4 kPa
    7.Participants must be able to comply with the instructions for study drug administration and be able to complete the study schedule of procedures
    E.4Principal exclusion criteria
    1.Clinically significant acute or chronic liver disease of an etiology other than PSC
    2.Patients with a diagnosis of overlapping AIH and/or small duct PSC
    3. Patients with a diagnosis of small-duct PSC
    4.Secondary or IgG4 related sclerosing cholangitis
    5.Presence of a cholangiocarcinoma on MRCP or MRI at Screening as determined by the central radiologist and the principal investigator (PI) or Medical Monitor
    6.Bile duct stent or percutaneous bile duct drain placement within 12 weeksof Screening
    7.Balloon dilation procedure of a stricture within 3 months of Screening
    8.History, evidence, or high suspicion of cholangiocarcinoma or other hepatobiliary malignancy based on imaging, screening laboratory values, and/or clinical symptoms
    9.Presumptive or diagnosed acute cholangitis within 12 weeks of Screening and through Day 1
    10.Evidence of compensated or decompensated cirrhosis based on histology, relevant medical complications, or laboratory parameters:

     Historical liver biopsy demonstrating cirrhosis (e.g., Ludwig Stage 4 or Ishak Stage ≥
    5)
     Current or prior history of decompensated liver disease, including ascites, hepatic
    encephalopathy, variceal bleeding or other clinical conditions consistent with
    cirrhosis and/or portal hypertension
     Liver stiffness > 14.4 kPa by FibroScan®
     Combined low platelet count (< 140 × 10
    3
    /µL) with one or more of the following:
    o Albumin < 3.5 g/dL,
    o INR > 1.3 (not due to antithrombotic agent use), or
    o Total bilirubin > ULN
    11. Variability > 40% in any one of the following laboratory parameters: AP, ALT, AST, or total bilirubin values between at least two visits during Screening approximately 4 weeks apart
    o If a lab value at Screening Visit 2 is > 40% higher than the lab value at Screening Visit 1, a third sample may be drawn. If the difference between the third sample and the value from Screening Visit 1 is also > 40% higher, the participant is excluded from the study
    12.Prior or actively listed for liver transplantation
    13. Any contraindication or inability to obtain a MRCP, MRI with contrast, FibroScan®, or colonoscopy (if required)
    14.Females who are pregnant or nursing
    •Specific criteria for defining child-bearing potential, acceptable methods of birth control and male partner recommendations are outlined in detail in Section 7.5.1 of the protocol
    15.ECG with clinically significant abnormalities as determined by the Investigator
    16.Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) RNA, or anti-human immunodeficiency virus (HIV) antibody
    17. History of malignancy diagnosed or treated within 2 years
     Recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted
     Cervical carcinoma in-situ is allowed if appropriately treated prior to Screening
    participants under active evaluation for malignancy are not eligible
    18.Clinically relevant drug or alcohol abuse within 24 weeks of Screening. A positive drug screen will exclude participants unless it can be explained by a prescribed medication
    19.Any prohibited medication as listed in Section 5.2.2 of the study protocol
    20.Prior exposure to seladelpar
    21.Use of obeticholic acid, vancomycin, minocycline, fibrates or any other experimental or unapproved agent for the treatment of PSC within 12 weeks of Screening and throughout the study period
    22.Participation in a study of another investigational agent within 4 weeks of the last study visit for that study or five half-lives of the investigational drug (whichever is longer) prior to Screening
    23.History of clinically significant unstable or untreated illness or any other acute or chronic medical condition that may interfere with participants treatment, assessment, or compliance with the protocol
    24.Presence of any other conditions (e.g., geographic or social), actual or projected, that the investigator feels would restrict or limit the patient’s participation for the duration of the study
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint, relative change in AP from Baseline to Week 24, will be analyzed using ANCOVA) model with treatment arm, UDCA
    stratification group (Yes/No) and total bilirubin stratification group (≤ ULN vs > ULN but ≤ 2 ×ULN) as factors. Baseline AP as a covariate on the observed cases on the FAS population will also be included in the model.. The statistical comparison of each seladelpar treatment arm against the placebo group on the primary endpoint will be made at a two-sided significance level of 0.0166, where the significance level of 0.0166 is the multiplicity-adjusted level using Bonferroni approach.
    E.5.1.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.5.2Secondary end point(s)
    The secondary endpoints will be analyzed descriptively. The confidence intervals of differences between each seladelpar treatment arm and the placebo arm will be provided. The ANCOVA and MMRM approaches used for the primary endpoint may also be applied to the secondary endpoints when applicable.
    E.5.2.1Timepoint(s) of evaluation of this end point
    24 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial4
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA18
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Germany
    Israel
    Poland
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Week 24 will be the End of Treatment (EOT) clinic visit. All participants eligible and willing can be enrolled into a separate 12 month open-label extension (OLE) study starting at Week 24. Participants who do not enrol in the OLE study participant will return to the clinic at Week 28 for an End of Study (EOS) follow-up visit
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months8
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 90
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state13
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 100
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    All subjects eligible and willing can be enrolled into a separate 52 week open-label extension (OLE) study starting at Week 24. Subjects who do not want to continue seladelpar treatment, the patient will have a End of Study visit: This study visit will happen about 4 weeks after the EOT visit and will only be done if the patient does not participate in the optional treatment extension study.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-07-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-10-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2020-01-09
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