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    Summary
    EudraCT Number:2018-003474-27
    Sponsor's Protocol Code Number:HepNet-aHCV-V
    National Competent Authority:Germany - BfArM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-01-23
    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 ConcernedGermany - BfArM
    A.2EudraCT number2018-003474-27
    A.3Full title of the trial
    Multicenter trial for the treatment of acute Hepatitis C for 8 weeks with Sofosbuvir/Velpatasvir fix dose combination - The HepNet Acute HCV-V study
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter trial for the treatment of acute Hepatitis C with Sofosbuvir/Velpatasvir
    A.3.2Name or abbreviated title of the trial where available
    HepNet Acute HCV-V study
    A.4.1Sponsor's protocol code numberHepNet-aHCV-V
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03818308
    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 SponsorHannover Medical School
    B.1.3.4CountryGermany
    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.4.1Name of organisation providing supportGerman Center for Infection Research (DZIF)
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHannover Medical School
    B.5.2Functional name of contact pointProf. Dr. Markus Cornberg
    B.5.3 Address:
    B.5.3.1Street AddressCarl-Neuberg-Str. 1
    B.5.3.2Town/ cityHannover
    B.5.3.3Post code30625
    B.5.3.4CountryGermany
    B.5.4Telephone number+495115326821
    B.5.6E-mailcornberg.markus@mh-hannover.de
    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 Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderGilead Sciences Ireland UC
    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.3.4Pharmaceutical 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.3.9.3Other 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.3.9.1CAS number 1377049-84-7
    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
    Adults with acute hepatitis C virus (HCV) infection
    E.1.1.1Medical condition in easily understood language
    Adults with acute hepatitis C virus infection
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.1
    E.1.2Level PT
    E.1.2Classification code 10065051
    E.1.2Term Acute 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 efficacy of treatment with sofosbuvir/velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) for 8 weeks in patients with acute HCV infection as measured by the proportion of subjects with sustained viral response (undetectable HCV RNA) 12 weeks after stop of therapy (SVR 12)
    E.2.2Secondary objectives of the trial
    • To evaluate the HCV RNA kinetics during treatment and after stop of therapy measured as mean viral load at baseline, week 2, 4, 8 (EOT) and 12 weeks after stop of therapy.
    • To determine ALT normalization (ALT <ULN) after 8 weeks (EOT) of therapy and 12 weeks after stop of therapy (FU 12)

    Assessment of safety:
    Adverse events (AEs) will be collected throughout the study (up to 12 weeks after discontinuation of therapy, FU12).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Willing and able to provide written informed consent
    2. Male or female, age > 18 years
    3. HCV RNA > 103 IU/mL at screening
    4. Confirmation of acute HCV infection documented by either:
    a. Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening
    b. Documented conversion to HCV RNA positivity within the 4 months preceding screening
    c. or known or suspected exposure to HCV within the 4 months preceding screening with 10 times elevated serum ALT level at screening or 4 months preceding screening without evidence of confounding liver disorders
    5. Body mass index (BMI) >18 kg/m2
    6. Subjects must have the following laboratory parameters at screening:
    a. INR < 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
    b. HbA1c <10%
    c. Creatinine clearance (CLcr) > 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight)
    7. A negative serum pregnancy test is required for female subjects (unless surgically sterile or women > 54 years of age with cessation for 24 > months of previously occurring menses). Complete abstinence from intercourse. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not permitted.
    Or
    Consistent and correct use of 1 of the following methods of birth control listed below, in addition to a male partner who correctly uses a condom, from the date of Screening until the end of FU:
    • intrauterine device (IUD) with a failure rate of < 1% per year
    • tubal sterilization
    • vasectomy in male partner
    • hormone-containing contraceptive:
    - implants of progestogen-only hormonal contraception associated with inhibition of ovulation
    - injectable progestogen-only hormonal contraception associated with inhibition of ovulation
    - oral contraceptives (either combined or progestogen-only hormonal contraception associated with inhibition of ovulation)
    - contraceptive vaginal ring
    - transdermal contraceptive patch
    8. Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments.
    E.4Principal exclusion criteria
    1. Subject has been treated with any investigational drug or device within 42 days of the Screening visit or within 5 half-lives for investigational drugs, whichever is longer
    2. Co-Infection with HIV
    3. Clinically-significant illness (other than HCV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol.
    4. Solid organ transplantation
    5. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
    6. Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
    7. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
    8. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 2 years. Subjects with psychiatric illness that is well-controlled on a stable treatment regimen for at least 12 months prior to screening or has not required medication in the last 12 months may be included.
    9. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
    10. Pregnant or nursing female
    11. Clinically-relevant drug or alcohol abuse that significantly impairs patient compliance. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study.
    12. Clinical relevant(not controlled) liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson’s disease, alpha1 antitrypsin deficiency, cholangitis)
    13. Use of any prohibited concomitant medications within 21 days before the Baseline/Day 1 visit. The use of amiodarone is prohibited from 60 days prior to Day 1 through the end of treatment
    14. Known hypersensitivity to SOF/VEL or formulation excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy (SVR 12)
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 weeks after discontinuation of therapy (SVR 12)
    E.5.2Secondary end point(s)
    • Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy

    • Proportion of subjects who reached ALT normalization (ALT <ULN) after 8 weeks of therapy (EOT) and 12 weeks after discontinuation of therapy (FU12)

    Assessment of safety:
    All adverse events will be collected throughout the study. Adverse events will be reported with absolute and relative frequencies for the whole study population.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy

    • after 8 weeks of therapy (EOT) and 12 weeks after discontinuation of therapy (FU12)
    • from baseline (informed consent)until the 12 weeks post-treatment visit.
    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 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) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned15
    E.8.5The trial involves multiple Member States No
    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 years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 18
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 2
    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.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)
    standard care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation HepNet Study House of German Liver Foundation
    G.4.3.4Network Country Germany
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-03-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-03-11
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2021-06-08
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