HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sofosbuvir Sofosbuvir 400 MG film-coated tablet, oral administration of one tablet once daily for 24 weeks. |
Drug: Sofosbuvir
Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Proportion of subjects who become HEV RNA negative after 24 weeks of therapy [after 24 weeks of therapy]
Measured by the proportion of subjects who become HEV RNA negative (HEV RNA undetectable)
Secondary Outcome Measures
- Proportion of subjects who are HEV RNA negative 12 weeks after discontinuation of therapy [12 weeks after discontinuation of therapy (week 36)]
Viral load measurement
- Additional efficacy evaluations include HEV RNA change from baseline during therapy [after 2 days, 4 days, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, and 24 weeks of therapy]
Viral load and laboratory measurements
- Comparison of proportion of patients who are HEV RNA negative after rapid or slow decline of HEV viral load after 24 weeks of therapy [after 24 weeks of therapy]
Viral load measurement
- Proportion of subject who reached ALT normalization after 12 weeks and 24 weeks of therapy and 12 weeks after discontinuation of therapy [after 12 and 24 weeks of therapy and 12 weeks after discontinuation of therapy (week 36)]
Laboratory measurement
- Assessment of safety: Adverse events and safety laboratory tests will be collected throughout the study [through study completion, an average of 36 weeks]
Collection of adverse events and safety laboratory tests
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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:
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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)
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Subject has not been treated with any investigational drug or device within 42 days of the Screening visit
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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
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female barrier method: cervical cap or diaphragm with spermicidal agent
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tubal sterilization
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vasectomy in male partner
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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 Criteria:
-
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.
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Infection with the hepatitis C virus (defined as HCV RNA positive)
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Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
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Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
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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.
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Significant drug allergy (such as anaphylaxis or hepatotoxicity).
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Pregnant or nursing female
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 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 |
Sponsors and Collaborators
- Hannover Medical School
- HepNet Study House, German Liverfoundation
- Gilead Sciences
- German Center for Infection Research
Investigators
- Principal Investigator: Markus Cornberg, Prof. Dr., Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HepNet-SofE
- 2017-000403-24