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    Summary
    EudraCT Number:2015-000178-36
    Sponsor's Protocol Code Number:VHCRP1309
    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:2016-01-22
    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 ConcernedUK - MHRA
    A.2EudraCT number2015-000178-36
    A.3Full title of the trial
    A phase II, open-label, single arm, multicentre, international trial of sofosbuvir and GS-5816 for people with chronic hepatitis C virus infection and recent injection drug use
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The purpose of this study to evaluate how effective, safe and tolerable SOF/GS-5816 is when taken for 12 weeks by people infected with HCV and who are recent injection drug users. For the purpose of this study anyone who has injected drugs in the previous 24 weeks is considered to be a recent injection drug user.
    A.3.2Name or abbreviated title of the trial where available
    simplify
    A.4.1Sponsor's protocol code numberVHCRP1309
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02336139
    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 SponsorUniversity of New South Wales
    B.1.3.4CountryAustralia
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    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 organisationUniversity of New South Wales
    B.5.2Functional name of contact pointPhilippa Marks
    B.5.3 Address:
    B.5.3.1Street AddressWallace Wurth Building, University of New South Wales
    B.5.3.2Town/ citySydney NSW
    B.5.3.3Post code2052
    B.5.3.4CountryAustralia
    B.5.4Telephone number61 2 93850886
    B.5.6E-mailpmarks@kirby.unsw.edu.au
    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.2.1.1.1Trade name Sovaldi
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Inc
    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/GS-5816
    D.3.4Pharmaceutical form 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/GS-5816
    D.3.9.2Current sponsor codeGS-7977 (sofosbuvir) / GS-5816
    D.3.9.3Other descriptive nameSOFOSBUVIR/GS-5816
    D.3.9.4EV Substance CodeAS1
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number400SOF/100GS-5816
    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 all genotypes
    E.1.1.1Medical condition in easily understood language
    Chronic hepatitis C is infection with the hepatitis C virus for more than 6 months.
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10019744
    E.1.2Term Hepatitis C
    E.1.2System Organ Class 10021881 - Infections and infestations
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following SOF/GS-5816 therapy for 12 weeks in people with chronic HCV infection and recent injection drug.
    E.2.2Secondary objectives of the trial
    To evaluate
    • the proportion adherent to therapy (both on-treatment adherence and treatment discontinuation);
    • the association between adherence and response to treatment [including an evaluation of the impact of early (0-3 weeks), mid (4-7 weeks) and late (8-11 weeks) missed doses on response to therapy];
    • factors associated with on-treatment adherence >90% and treatment discontinuation;
    • the proportion with undetectable HCV RNA at the end of treatment (ETR);
    • safety and tolerability;
    • the change in drug use during treatment;
    • the change in mental health during treatment;
    • the change in health-related quality of life during treatment;
    • mixed HCV infection at baseline and among those with treatment non-response;
    • the rate of HCV reinfection during and up to two years following treatment;
    • immunovirological factors associated with treatment clearance;
    • the utility of dried blood spot as a simple method for monitoring HCV including treatment response.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    At selected sites peripheral blood mononuclear cells (PBMCs) will be collected at the time points specified in the protocol. These will be used for immunovirological research aims. Not all sites will participate in this sub-study as not all sites have the capacity and ability to process and store PBMCs.
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible to participate in this study.
    1 Participants have voluntarily signed the informed consent form.
    2 18 years of age or older.
    3 Chronic HCV infection as defined by anti-HCV antibody or HCV RNA detection for greater than 6 months.
    4 HCV RNA plasma ≥ 1000 IU/ml at Screening.
    5 HCV genotypes 1-6.
    6 Recent injecting drug use (previous 6 months).
    7 Compensated liver disease. Enrolment of patients with cirrhosis (Fibroscan >14.6 kPa or FIB-4 > 3.25) will be capped to 40% of the total enrolment (maximum 2 per site).
    8 Participants with Fibroscan >12 KPa or AFP >50 ng/mL must have an abdominal ultrasound or CT scan without evidence of hepatocellular carcinoma within 2 months prior to screening.
    9 Negative pregnancy test at baseline (females of childbearing potential only)
    10 All fertile males and females must be using effective contraception during treatment and during the 30 days after treatment end.
    E.4Principal exclusion criteria
    Subjects who meet any of the exclusion criteria are not to be enrolled in this study.

    1 History of any of the following:
    a. Clinically significant illness (other than HCV) or any other major medical disorder that may interfere with the participant treatment, assessment or compliance with the protocol; participants currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded.
    b. Clinical hepatic decompensation (i.e. ascites, encephalopathy or variceal haemorrhage)
    c. Solid organ transplant
    d. Malignancy within 5 years prior to screening, with exception of specific cancers that may have been cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are also excluded.
    e. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
    2 Screening ECG with clinically significant abnormalities
    3 Any of the following lab parameters at screening:
    a. ALT > 10 x ULN
    b. AST > 10 x ULN
    c. Direct bilirubin > 1.5 x ULN
    d. Platelets < 50,000/μL
    e. HbA1c > 8.5%
    f. Creatinine clearance (CLcr) < 60 mL/min
    g. Haemoglobin < 11 g/dL for females ; < 12 g/dL for males
    h. Albumin < 30g/L
    i. INR > 1.5 ULN unless subject has known haemophilia or is stable on an anticoagulant regimen affecting INR
    4 Pregnant or nursing female.
    5 HIV infection or HBV infection (HBcAb and HBsAg positive)
    6 Use of prohibited concomitant medications as described in section 5.2
    7 Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day)
    8 Known hypersensitivity to GS-5816, SOF or formulation excipients.
    9 Therapy with any anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) *6 months prior to the first dose of study drug.
    10 Any investigational drug ≤6 weeks prior to the first dose of study drug.
    11 Previous therapy with sofosbuvir or an NS5A inhibitor prior to the first dose of study drug.
    12 Ongoing severe psychiatric disease as judged by the treating physician.
    13 Frequent injecting drug use that is judged by the treating physician to compromise treatment safety.
    14 Inability or unwillingness to provide informed consent or abide by the requirements of the study.
    E.5 End points
    E.5.1Primary end point(s)
    SVR12 defined as the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (week 24).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Week 24
    E.5.2Secondary end point(s)
    1. Proportion adherent to therapy (on-treatment adherence and treatment discontinuation).
    2. SVR4 defined as the proportion of patients with undetectable HCV RNA at 4 weeks post end of treatment (week 16).
    3. ETR defined as the proportion of patients with undetectable HCV RNA at the end of treatment (week 12)
    4. SVR24 defined as the proportion of patients with undetectable HCV RNA at 24 weeks post the end of treatment (week 36).
    5. Change in illicit drug use during treatment;
    6. Change in mental health during treatment;
    7. Change in health-related quality of life during treatment;
    8. Rate of HCV reinfection during and up to two years following treatment.

    Assessments of safety
    Safety endpoints:
    1. Adverse event rate and profile will be monitored for:
    a. Incidence of moderate or severe depression
    2. Other laboratory tests will be monitored for:
    a. Incidence of anemia, leucopenia and thrombocytopenia
    b. Incidence of infections
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Week 12
    2. Week 16
    3. Week 12
    4. Week 24
    5. Week 12
    6. Week 12
    7. Week 12
    8. Week 108

    Assessments of safety
    Safety endpoints:
    1a. Week 16
    2a. Week 16
    2b. Week 16
    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 No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 No
    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 concerned2
    E.8.5The trial involves multiple Member States No
    E.8.5.1Number of sites anticipated in the EEA3
    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
    New Zealand
    Norway
    Switzerland
    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 years2
    E.8.9.1In the Member State concerned months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months2
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1Number of subjects for this age range: 0
    F.1.1.1In Utero No
    F.1.1.1.1Number of subjects for this age range: 0
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.2.1Number of subjects for this age range: 0
    F.1.1.3Newborns (0-27 days) No
    F.1.1.3.1Number of subjects for this age range: 0
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.4.1Number of subjects for this age range: 0
    F.1.1.5Children (2-11years) No
    F.1.1.5.1Number of subjects for this age range: 0
    F.1.1.6Adolescents (12-17 years) No
    F.1.1.6.1Number of subjects for this age range: 0
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 15
    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. Treatment is for a maximum of 12 weeks. There is no evidence to suggest that treatment for longer than 12 weeks in this population with this regimen will provide any added benefit.
    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 Decision2016-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-04-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-11-28
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