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    Summary
    EudraCT Number:2016-000416-15
    Sponsor's Protocol Code Number:GS-US-342-2104
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-04-13
    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 number2016-000416-15
    A.3Full title of the trial
    A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination in Subjects with Chronic HCV Infection who have Received a Liver Transplant
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A trial investigating the safety and efficacy of a drug combination Sofosbuvir/Velpatasvir for subjects with hepatitis C
    A.4.1Sponsor's protocol code numberGS-US-342-2104
    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 International Ltd.
    B.5.2Functional name of contact pointClinical Trials Mailbox
    B.5.3 Address:
    B.5.3.1Street AddressGranta Park
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeCB21 6GT
    B.5.3.4CountryUnited States
    B.5.5Fax number+441223897284
    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.3.1Product namesofosbuvir/velpatasvir
    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 INNvelpatasvir
    D.3.9.2Current sponsor codeGS-5816
    D.3.9.3Other descriptive namevelpatasvir
    D.3.9.4EV Substance CodeSUB180213
    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.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 19.0
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10019754
    E.1.2Term Hepatitis cholestatic
    E.1.2System Organ Class 10019805 - Hepatobiliary disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of study treatment with sofosbuvir (SOF)/velpatasvir (VEL) FDC for 12 weeks as measured by the proportion of subjects with sustained virologic response 12 weeks after cessation of study treatment regimen (SVR12)

    To evaluate the safety and tolerability of the study treatment regimen
    E.2.2Secondary objectives of the trial
    To determine the proportion of subjects who attain SVR at 4 weeks after cessation of the study treatment regimen (SVR4)

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

    To evaluate the emergence of viral resistance to SOF and VEL during study treatment and after cessation of study treatment regimen
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenomics (PG) Substudy
    In consenting participants, blood samples will be drawn at Baseline or during the study for pharmacogenomics research.
    E.3Principal inclusion criteria
    1) Willing and able to provide written informed consent
    2) Males and females, age ≥ 18 years old
    3) Chronic HCV infection (≥6 months) documented pretransplantation by prior medical history or liver biopsy
    4) HCV RNA ≥ 104 IU/mL at screening
    5) No clinical signs of rejection for 3 months prior to the Screening visit
    6) Primary or secondary (re-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor (regardless of the HCV status of the liver donor)
    7) Liver transplant ≥ 3 months prior to screening
    8) A body mass index (BMI) of ≥ 18 kg/m2
    9) Subjects must have a determination of treatment experience (see protocol for details).
    10) Subjects must have appropriate testing for determination of cirrhosis status (see protocol for details).
    11) Liver imaging within 6 months of Baseline/Day 1 is required in cirrhotic subjects only to exclude hepatocellular carcinoma (HCC)
    12) A negative serum pregnancy test is required for female subjects (unless permanently sterile or greater than two years post-menopausal)
    13) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
    14) Lactating females must agree to discontinue nursing before the study drug is administered
    15) 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) Multi-organ transplant that includes heart or lung recipient (patients who have their liver transplant as part of a liver-kidney dual transplant are eligible to enroll)
    2) Subjects with de novo or recurrent Hepatocellular Carcinoma (HCC) posttransplant
    3) Current use of corticosteroids at any dose >5mg of prednisone/day (or equivalent dose of corticosteroid)
    4) Child-Pugh-Turcotte (CPT) Score >7 at Screening
    5) Recipient of ABO incompatible organ
    6) Histological evidence of unresolved rejection
    7) Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) at Screening
    8) Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
    9) Serum creatinine >2.5x upper limit of normal (ULN) or stage 4 chronic kidney disease (CrCl<30ml/min)
    10) Screening ECG with clinically significant abnormalities
    11) Subjects with the laboratory results (as defined in the protocol) at Screening are excluded unless enrollment is approved by the sponsor medical monitor
    12) Use of GM-CSF, epoetin alfa or other therapeutic agents within 2 weeks of Screening
    13) History of other clinically relevant chronic liver disease (e.g., hemochromatosis, autoimmune hepatitis, Wilson’s disease, α-1-antitrypsin deficiency, alcoholic liver disease, non-alcoholic steatohepatitis, or toxin exposure)
    14) Recent (within 4 weeks of Screening) episode or infection requiring systemic antibiotics
    15) Use or planned use of T-cell depleting/masking antibodies, systemic antineoplastic agents, cyclosporine >300mg/day,or use of any prohibited medications listed in Section 5.4 within 28 days of the Baseline/Day 1 visit
    16) Prior exposure to any HCV NS5A inhibitor
    17) History or current evidence of immunologic disorder, hemoglobinopathy, pulmonary or cardiac disease, porphyria, seizure disorder, poorly controlled diabetes, pancreatitis with elevated lipase, cancer, or a history of malignancy (with exception of certain resolved skin cancers or pre-transplant hepatocellular carcinoma; patients who received liver transplants for hepatocellular carcinoma must be 5 years post-transplant with no evidence of recurrence at Screening) that in the opinion of the investigator makes the subject unsuitable for the study
    18) Treatment for HCV infection with experimental or approved regimens within 3 months of Baseline/Day 1.
    19) Participation in a clinical study with an investigational drug, or biologic within 3 months prior to Baseline/Day 1
    20) Clinically relevant alcohol or drug abuse within 12 months of Screening. A positive drug screen will exclude subjects unless it can be explained by prescribed medications; the diagnosis and prescription must be approved by the investigator
    21) History or difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
    22) Known hypersensitivity to SOF (and the metabolites), and/or VEL
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is SVR12 (HCV RNA < LLOQ 12 weeks after cessation of study treatment regimen) in the Full Analysis Set (FAS).

    The primary safety endpoint is any AE that led to permanent discontinuation of study drug.
    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 secondary efficacy endpoints include the proportion of subjects who attain sustained virologic response at 4 weeks after cessation of the study treatment regimen (SVR4); the proportion of subjects who have HCV RNA < LLOQ by visit while on study treatment; absolute and change from baseline/Day 1 in HCV RNA through Week 12; and the proportion of subjects with virologic failure.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The efficacy endpoints are evaluated 4 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 Yes
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA17
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    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 months1
    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 months1
    E.8.9.2In all countries concerned by the trial days0
    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: 70
    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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2016-04-13. Yes
    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 state28
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 80
    F.4.2.2In the whole clinical trial 80
    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)
    None
    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 Decision2016-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-14
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2017-07-28
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