Status:
COMPLETED
HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)
Lead Sponsor:
Hannover Medical School
Collaborating Sponsors:
HepNet Study House, German Liverfoundation
Gilead Sciences
Conditions:
Hepatitis E
Hepatitis Chronic Viral
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This is a single arm multicenter pilot study to provide preliminary evidence whether sofosbuvir (SOF) is efficacious and can be safely used in patients with chronic Hepatitis E virus infection.
Eligibility Criteria
Inclusion
- Willing and able to provide written informed consent
- Male or female, age ≥ 18 years
- 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
- Documented previous ribavirin therapy or documented contraindication for full dose (≥ 600mg qd) ribavirin monotherapy for at least 3 months
- Body mass index (BMI) ≥ 18 kg/m2
- Screening ECG without clinically significant abnormalities
- 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)
- Subject has not been treated with any investigational drug or device within 42 days of the Screening visit
- 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
- Subject must be able to comply with the dosing instructions for study drug administration and be able to complete the study schedule of assessments.
Exclusion
- 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.
- Ribavirin administration within the last 28 days.
- Infection with the hepatitis C virus (defined as HCV RNA positive)
- Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
- 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 wellcontrolled 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.
- Significant drug allergy (such as anaphylaxis or hepatotoxicity).
- Pregnant or nursing female
- 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.
- 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/Day1 visit.
- Known hypersensitivity to SOF or formulation excipients.
Key Trial Info
Start Date :
December 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 18 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03282474
Start Date
December 7 2017
End Date
February 18 2019
Last Update
March 8 2019
Active Locations (3)
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1
Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
Hanover, Lower Saxony, Germany, 30625
2
Charité, Campus Virchow-Klinikum, Medical Department, Division of Hepatology and Gastroenterology
Berlin, Germany, 13353
3
University Medical Center Hamburg-Eppendorf, Center for Internal Medicine, I. Medical Clinic and Polyclinic
Hamburg, Germany, 20246