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    Summary
    EudraCT Number:2017-000403-24
    Sponsor's Protocol Code Number:HepNet-SofE
    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:2017-09-08
    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 number2017-000403-24
    A.3Full title of the trial
    HepNet pilot trial: Multicenter trial for the treatment of chronic hepatitis E with sofosbuvir (SofE)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Multicenter trial for the treatment of chronic hepatitis E with sofosbuvir
    A.3.2Name or abbreviated title of the trial where available
    HepNet-SofE study
    A.4.1Sponsor's protocol code numberHepNet-SofE
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03282474
    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 Sovaldi® 400 mg Filmtabletten
    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.3.4Pharmaceutical 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.3.11 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 chronic Hepatitis E virus infection, who either failed to achieve clearance of infection after ribavirin therapy or have contraindications for ribavirin.
    E.1.1.1Medical condition in easily understood language
    Adults with chronic Hepatitis E virus infection, who either failed to achieve clearance of infection after standard therapy or have contraindications for standard therapy.
    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 10019768
    E.1.2Term Hepatitis E
    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 sofosbuvir (SOF) against HEV as measured by the proportion of subjects who become HEV RNA negative (HEV RNA undetectable) after 24 weeks of therapy
    • To evaluate the safety and tolerability of SOF-containing regimens administered for up to 24 weeks in patients with chronic HEV infection
    E.2.2Secondary objectives of the trial
    • To evaluate if SOF has an antiviral activity against HEV in patients with chronic hepatitis E determined by viral load declines after 2, 4, 7 (w1), 14 (w2), 28 (w4), 56 (w8), 84 (w12), 112 (w16), 140 (w20), and 168 (w24) days of treatment
    • To evaluate if rapid (>2log within 2 weeks of treatment), vs slow decline of HEV viral load has an influence on reaching HEV RNA negativity
    • To determine ALT normalization after 12 weeks and 24 weeks of therapy and 12 weeks after discontinuation of therapy (FU12 visit)
    • To determine the durability of response 12 weeks after discontinuation of therapy (HEV RNA negative)

    Assessment of safety:
    Adverse events (AEs) and safety laboratory tests 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. Confirmation of chronic HEV infection documented by:
    Positive HEV RNA at least 3 months before Screening, and positive for HEV RNA at the time of Screening
    4. Documented previous ribavirin therapy or documented contraindication for full dose (≥ 600mg qd) ribavirin monotherapy for at least 3 months
    5. Body mass index (BMI) ≥18 kg/m2
    6. Screening ECG without clinically significant abnormalities
    7. Subjects must have the following laboratory parameters at screening:
    • Platelets ≥ 60,000/µL
    • INR ≤ 2.0 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR
    • HbA1c ≤ 10%
    • Creatinine clearance (CLcr) ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight)
    8. Subject has not been treated with any investigational drug or device within 42 days of the Screening visit
    9. 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 30 days after last dose of study drug:
    • intrauterine device (IUD) with a failure rate of < 1% per year
    • female barrier method: cervical cap or diaphragm with spermicidal agent
    • tubal sterilization
    • vasectomy in male partner
    • hormone-containing contraceptive:
    - implants of levonorgestrel
    - injectable progesterone
    - oral contraceptives (either combined or progesterone only)
    - contraceptive vaginal ring
    - transdermal contraceptive patch
    10. 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. Clinically-significant illness (other than HEV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol.
    2. Ribavirin administration within the last 28 days.
    3. Infection with the hepatitis C virus (defined as HCV RNA positive)
    4. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
    5. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
    6. 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.
    7. Significant drug allergy (such as anaphylaxis or hepatotoxicity).
    8. Pregnant or nursing female
    9. Clinically-relevant drug or alcohol abuse within 12 months of screening including any uncontrolled drug use within 6 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. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study.
    10. Use of any prohibited concomitant medications within 21 days of the Baseline/Day 1 visit. Use of amiodaron as concomitant medication is prohibited within 60 days of Baseline/Day 1 visit.
    11. Known hypersensitivity to SOF or formulation excipients.
    E.5 End points
    E.5.1Primary end point(s)
    Proportion of subjects who become HEV RNA negative after 24 weeks of therapy
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 24 weeks of therapy
    E.5.2Secondary end point(s)
    1. Proportion of subjects who are HEV RNA negative 12 weeks after discontinuation of therapy
    2. Additional efficacy evaluations include HEV RNA change from baseline during therapy
    3. Comparison of proportion of patients who are HEV RNA negative after rapid or slow decline of HEV viral load after 24 weeks of therapy.
    4. Proportion of subject who reached ALT normalization after 12 weeks and 24 weeks of therapy and 12 weeks after discontinuation of therapy (FU12 visit)

    5. Assessment of safety:
    Adverse events (AEs) and safety laboratory tests will be collected throughout the study (up to 12 weeks after discontinuation of therapy, FU12).
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. 12 weeks after discontinuation of therapy
    2. Throughout the study
    3. After 24 weeks of therapy
    4. 12 weeks and 24 weeks of therapy and 12 weeks after discontinuation of therapy
    5. Throughout the study until 12 weeks after discontinuation of therapy
    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 concerned3
    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 years1
    E.8.9.1In the Member State concerned months3
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 1
    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.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 the 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 Decision2017-09-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-10-17
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-02-18
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