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    Summary
    EudraCT Number:2014-001682-27
    Sponsor's Protocol Code Number:GS-US-342-1140
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-06-22
    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 ConcernedFrance - ANSM
    A.2EudraCT number2014-001682-27
    A.3Full title of the trial
    A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks with Sofosbuvir and Ribavirin for 24 Weeks in Subjects with Chronic Genotype 3 HCV Infection
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial looking at the treatment of SOF/GS-5816 for 12 weeks against the treatment of Sofosbuvir and Ribavirin for 24 weeks in patients with hepatitis C infection
    A.4.1Sponsor's protocol code numberGS-US-342-1140
    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 SponsorGilead Sciences, Inc.
    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 supportGilead Sciences Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGilead Sciences Inc.
    B.5.2Functional name of contact pointMedical Monitor
    B.5.3 Address:
    B.5.3.1Street Address333 Lakeside Drive
    B.5.3.2Town/ cityFoster City
    B.5.3.3Post codeCA, 94404
    B.5.3.4CountryUnited States
    B.5.4Telephone number+16505743000
    B.5.5Fax number+16505789264
    B.5.6E-mailclinical.trials@gilead.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.3.2Product code SOF/GS-5816 FDC
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSofosbuvir
    D.3.9.1CAS number 1190307-88-0
    D.3.9.2Current sponsor codeGS-7977
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGS-5816
    D.3.9.2Current sponsor codeGS-5816
    D.3.9.3Other descriptive nameGS-5816
    D.3.9.4EV Substance CodeSUB117293
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Sovaldi
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International Ltd
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameSofosbuvir
    D.3.2Product code GS-7977
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNSofosbuvir
    D.3.9.1CAS number 1190307-88-0
    D.3.9.2Current sponsor codeGS-7977
    D.3.9.3Other descriptive nameSOFOSBUVIR
    D.3.9.4EV Substance CodeSUB121170
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400
    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 RoleComparator
    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 Yes
    D.2.1.1.1Trade name Ribasphere
    D.2.1.1.2Name of the Marketing Authorisation holderThree Rivers Pharmaceuticals LLC
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameRibavirin
    D.3.4Pharmaceutical form Film-coated tablet
    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 INNRibavirin
    D.3.9.1CAS number 36791-04-5
    D.3.9.3Other descriptive nameRIBAVIRIN
    D.3.9.4EV Substance CodeSUB10297MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Chronic Hepatitis C Virus Infection
    E.1.1.1Medical condition in easily understood language
    Hepatitis C
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level PT
    E.1.2Classification code 10008912
    E.1.2Term Chronic hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objectives of this study are:

    * To compare the efficacy of treatment with sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) for 12 weeks with
    that of SOF + ribavirin (RBV) for 24 weeks as measured by the proportion of subjects with sustained viral response 12 weeks
    after cessation of treatment (SVR12)

    * To evaluate the safety and tolerability of each treatment regimen
    E.2.2Secondary objectives of the trial
    The secondary objectives of this study are:

    * To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of each treatment regimen (SVR4 and SVR24)

    * To evaluate the proportion of subjects with virologic failure

    * To evaluate the kinetics of circulating HCV RNA during treatment and after cessation of each treatment regimen

    * To evaluate the emergence of viral resistance to SOF and GS-5816 during treatment and after cessation of treatment
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Optional Pharmacogenomics (PG) Substudy
    All subjects will be eligible to participate in the PG substudy.
    For subjects who provide separate consent for optional genetic testing, an additional blood sample will be obtained for possible genetic discovery research to identify or validate genetic markers (e.g., pharmacogenomics) that may be predictive of the safety and/or tolerability of study drug used in this protocol. This sample is recommended to be collected at the Baseline/Day 1 visit, but may be collected at any time during the study or at a separate post-study visit, if necessary.
    E.3Principal inclusion criteria
    1) Willing and able to provide written informed consent
    2) Male or female, age greater than or equal to 18 years
    3) HCV RNA greater than or equal to x 10 000 IU/mL at Screening
    4) HCV genotype 3 determined at Screening by the Central Laboratory. Any non-definitive results will exclude the subject from study participation
    5) Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
    6) Classification as treatment naïve or treatment experienced:
    a) Treatment naïve is defined as having never been exposed to approved or experimental HCV-specific direct-acting antiviral agents or prior treatment of HCV with interferon or ribavirin
    b) Treatment experienced is defined as prior treatment failure to a regimen containing interferon either with or without RBV that was completed at least 8 weeks prior to Baseline/Day 1. Subject must not have discontinued the prior regimen that resulted in virologic failure due to an adverse event.
    i) The subject’s medical records must include sufficient detail of prior virologic failure to allow for categorization of prior response, as either:
    (1) Non-Responder: Subject did not achieve undetectable HCV RNA levels while on treatment, or
    (2) Relapse/Breakthrough: Subject achieved undetectable HCV RNA levels during treatment or within 4 weeks of the end of treatment but did not achieve SVR
    7) Cirrhosis determination (approximately 20% of subjects may have cirrhosis)
    a. Cirrhosis is defined as any one of the following
    i) Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score >/= 5)
    ii) FibroTest® score > 0.75 AND an AST:platelet ratio index (APRI) > 2 during Screening
    iii) Fibroscan with a result of >12.5 kPa
    b. Absence of cirrhosis is defined as any one of the following:
    i) Liver biopsy within 2 years of Screening showing absence of cirrhosis
    ii) FibroTest® score ≤ 0.48 AND APRI ≤ 1 performed during Screening
    iii. Fibroscan with a result of ≤ 12.5 kPa within ≤ 6 months of Baseline/Day 1
    In the absence of a definitive diagnosis of presence or absence of cirrhosis by Fibrotest® /APRI using the above criteria, a liver biopsy or fibroscan is required; liver biopsy results will supersede Fibrotest® /APRI or fibroscan results and be considered definitive.
    8) Liver imaging within 6 months of Baseline/Day 1 is required in patients with cirrhosis to exclude hepatocellular carcinoma (HCC)
    9) Females of childbearing potential (as defined in Appendix 4) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test on Baseline/Day 1 prior to randomization.
    10) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 4.
    11) Lactating females must agree to discontinue nursing before the study drug is administered
    12) Subject must be of generally good health, with the exception of chronic HCV infection, as determined by the Investigator
    13) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments.
    E.4Principal exclusion criteria
    1) Current or prior history of any of the following:
    a. Clinically-significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
    b. Gastrointestinal disorder or post operative condition that could interfere with the absorption of the study drug.
    c. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
    d. Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
    e. Solid organ transplantation.
    f. Significant pulmonary disease, significant cardiac disease or porphyria.
    g. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years. Subjects with psychiatric illness (without the prior mentioned conditions) that is well-controlled on a stable treatment regimen for at least 12 months prior to randomization or has not required medication in the last 12 months may be included.
    h. Malignancy within the 5 years prior to screening, with the exception of specific cancers that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under evaluation for possible malignancy are not eligible.
    i. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
    2) Screening ECG with clinically significant abnormalities
    3) Subjects has the following laboratory parameters at screening:
    a) ALT > 10 x the upper limit of normal (ULN)
    b) AST > 10 x ULN
    c) Direct bilirubin > 1.5 x ULN
    d) Platelets < 50,000/microlitre
    e) HbA1c > 8.5%
    f) Creatinine clearance (CLcr) < 60 mL /min, as calculated by the Cockcroft-Gault equation
    g) Hemoglobin < 11 g/dL for female subjects; < 12 g/dL for male subjects.
    h) Albumin < 3 g/dL
    i) INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR.
    4) Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor.
    5) Pregnant or nursing female or male with pregnant female partner.
    6) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa-1 antitrypsin deficiency, cholangitis).
    7) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
    8) Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug screen will exclude subjects unless it can be explained by a prescribed medication; the diagnosis and prescription must be approved by the investigator.
    9) Use of any prohibited concomitant medications as described in Section 5.6
    10) Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
    11) Known hypersensitivity to GS-5816, RBV, SOF, or formulation excipients.
    12) History of clinically significant hemoglobinopathy (e.g., sickle cell disease, thalassemia)
    13) Contraindications to RBV therapy
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is SVR12 (HCV RNA <LLOQ 12 weeks after cessation of therapy) in the Full Analysis Set (FAS) population

    The primary safety endpoint is any AE leading to permanent discontinuation of study drug(s).
    E.5.1.1Timepoint(s) of evaluation of this end point
    The safety and tolerability endpoints are evaluated during the course of treatment. The efficacy endpoint is evaluated 12 weeks after discontinuation of therapy.
    E.5.2Secondary end point(s)
    - The proportion of subjects with: HCV RNA < LLOQ at 4 and 24 weeks after completion of therapy (SVR4 and SVR24)
    - The proportion of subjects with HCV RNA < LLOQ on treatment
    - HCV RNA change from Baseline/Day 1
    - The proportion of subjects with virologic failure
    E.5.2.1Timepoint(s) of evaluation of this end point
    The efficacy endpoints are evaluated 4 and 24 weeks after discontinuation of therapy.

    The other endpoints are evaluated during the course of treatment.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Sofosbuvir and Ribavirin for 24 weeks
    E.8.2.4Number of treatment arms in the trial2
    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 concerned11
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA33
    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
    France
    Germany
    Italy
    New Zealand
    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
    LVLS
    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 months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial days7
    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: 450
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 50
    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 state110
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 330
    F.4.2.2In the whole clinical trial 500
    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)
    Subjects who do not achieve SVR will be eligible for enrollment in an observational Sequence Registry Study. The purpose of the Sequence Registry Study will be to monitor the persistence of HCV resistant mutations.

    Subjects who achieve SVR will be eligible for enrollment in an observational SVR Registry Study. The purpose of the SVR Registry Study will be to evaluate durability of SVR.
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-08-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-08-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2015-12-15
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