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    Summary
    EudraCT Number:2016-003625-42
    Sponsor's Protocol Code Number:GS-US-342-4062
    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:2016-12-21
    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 number2016-003625-42
    A.3Full title of the trial
    A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir for 12 Weeks in Subjects with Chronic HCV Infection Who are on Dialysis for End Stage Renal Disease
    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 who are on dialysis for kidney disease.
    A.4.1Sponsor's protocol code numberGS-US-342-4062
    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 Kingdom
    B.5.4Telephone 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 Yes
    D.2.1.1.1Trade name Epclusa 400 mg/100 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences International
    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 nameEpclusa
    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 19.1
    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 19.1
    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
    • To evaluate the antiviral efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 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 the treatment regimen
    E.2.2Secondary objectives of the trial
    • To determine the proportion of subjects who attain SVR at 4 and 24 weeks after cessation of the study 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 treatment
    • To evaluate the emergence of viral resistance to SOF and VEL during treatment and after cessation of treatment
    • To evaluate the steady-state pharmacokinetics of SOF and its metabolites and VEL in subjects who are on dialysis for End Stage Renal Disease (ESRD)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacokinetic (PK) Substudies
    Subjects may consent to participate in either or both PK substudies.
    Intensive PK Substudy
    In consenting participants (target n=15), serial blood samples will be collected once at the Week 6, 8, or 12 on treatment visit at the following timepoints:
    0 (pre-dose -5 minutes), 0.25, 0.5, 1, 2, 4, 6, 8, 10, and 12 hours post-dose
    Plasma concentrations of SOF and VEL and its metabolites will be determined and PK parameters will be estimated as appropriate.
    Hemodialysis PK Substudy
    In consenting participants, (target n=10), blood samples will be collected at one hemodialysis session between Week 6 and Week 12, inclusive. A single blood sample will be collected within 10 minutes before hemodialysis initiates. During hemodialysis, a single sample will be collected from both the arterial and venous sides of the dialyzer approximately 1 hour prior to conclusion of hemodialysis. Finally, a single blood sample will be collected within 10 minutes after hemodialysis concludes.
    Plasma concentrations of SOF and VEL and its metabolites will be determined and hemodialysis extraction ratio and fraction of dose removed by dialysis will be estimated as appropriate.

    Pharmacogenomics (PG) Substudy
    In consenting participants, blood sample should be drawn at the Baseline/Day 1 visit. If not obtained at Baseline/Day1 visit, the sample may be drawn at any time during the study.
    E.3Principal inclusion criteria
    1) Willing and able to provide written informed consent
    2) Male or female age ≥ 18 years
    3) Chronic HCV infection (≥ 6 months) as documented by prior medical history or liver biopsy
    4) HCV RNA ≥ LLOQ at screening
    5) End stage renal disease (ESRD) requiring peritoneal dialysis (PD) or hemodialysis (HD)
    6) The most recent HCV treatment must have been completed at least 8 weeks prior to Screening
    7) Subjects must have a determination of treatment experience (treatment naïve vs. treatment experienced). Treatment naïve is defined as having never been exposed to an approved or experimental HCV-specific direct acting antiviral agents or prior treatment of HCV with interferon or ribavirin. All other patients will be considered treatment experienced.
    8) Subjects must have appropriate testing for determination of cirrhosis status.
    9) Liver imaging within 6 months of Baseline/Day 1 is required in cirrhotic subjects only to exclude hepatocellular carcinoma (HCC)
    10) Subjects with HIV-1 coinfection may be eligible, provided they satisfy additional inclusion criteria.
    11) A negative serum pregnancy test is required for female subjects (unless permanently sterile or greater than two years post-menopausal).
    12) 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.
    13) Lactating females must agree to discontinue nursing before the study drug is administered.
    14) 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
    b) Current or prior history of significant cardiac disease
    c) Gastrointestinal disorder or postoperative condition that could interfere with the absorption of the study drug.
    d) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
    e) Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
    f) Solid organ transplantation other than failed kidney transplants (current use of ≤5 mg/day of prednisone, or equivalent dose of corticosteroid, allowed).
    g) Significant pulmonary disease
    h) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years.
    i) 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
    2) Screening ECG with clinically significant abnormalities
    3) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alfa 1 antitrypsin deficiency, cholangitis).
    4) Infection with hepatitis B virus (HBV).
    5) Opportunistic infection (reference Appendix 5) within 6 months prior to Screening
    6) Infection (other than HIV or HCV) requiring parenteral therapy within 30 days prior to baseline.
    7) Life threatening SAE during the screening period
    8) 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. For subjects receiving ritonavir boosted atazanavir regimen, a direct bilirubin > 1.5 xULN will be allowed if < 25% of the total bilirubin
    d) Platelets < 25,000/μL
    e) HbA1c > 9%
    f) Hemoglobin < 9 g/dL
    g) Albumin < 2.8 g/dL
    h) INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
    i) Hepatitis B surface antigen positive
    9) Prior exposure to any HCV NS5A inhibitor.
    10) Male with pregnant female partner.
    11) Females who may wish to become pregnant and/or plan to undergo egg harvesting during the course of the study and up to 30 days of the last dose of study drug
    12) Males who may wish to donate sperm during the course of the study until at least 30 days after the last dose of study drug
    13) 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.
    14) Use of any prohibited concomitant medications as described in Section 5.4.
    15) Subjects with HIV-1 coinfection cannot be receiving an ARV regimen containing efavirenz (EFV)
    16) Chronic use of systemically administered immunosuppressive agents (e.g., prednisone equivalent > 10 mg/day).
    17) Known hypersensitivity to the VEL, SOF, the metabolites, or formulation excipient.
    18) For subjects with HIV-1 coinfection only:
    • HIV-1 RNA >50 copies/mL
    • CD4 T-cell count <100 cells/mm3
    • HIV-2 positive test
    E.5 End points
    E.5.1Primary end point(s)
    The primary end point is SVR12 (HCV RNA < LLOQ 12 weeks after cessation of treatment) in the Full Analysis Set (FAS) population.
    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
    SVR 12 weeks
    E.5.2Secondary end point(s)
    • The proportion of subjects with HCV RNA < LLOQ at 4 and 24 weeks after cessation of treatment (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
    • The proportion of subjects who develop viral resistance to SOF and VEL during treatment and after cessation of treatment
    • The steady-state pharmacokinetics of SOF and its metabolite and VEL
    E.5.2.1Timepoint(s) of evaluation of this end point
    • SVR 4 and 24 weeks
    • PK Day 7
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Israel
    New Zealand
    Spain
    United Kingdom
    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 months5
    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: 95
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    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 state20
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    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)
    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 Decision2017-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-24
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-07
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