- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03282474
HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
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Berlin, Germany, 13353
- Charité, Campus Virchow-Klinikum, Medical Department, Division of Hepatology and Gastroenterology
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Hamburg, Germany, 20246
- University Medical Center Hamburg-Eppendorf, Center for Internal Medicine, I. Medical Clinic and Polyclinic
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Lower Saxony
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Hanover, Lower Saxony, Germany, 30625
- Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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:
- 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 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.
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sofosbuvir
Sofosbuvir 400 MG film-coated tablet, oral administration of one tablet once daily for 24 weeks.
|
Sofosbuvir 400 MG Oral Tablet [Sovaldi]
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects who become HEV RNA negative after 24 weeks of therapy
Time Frame: after 24 weeks of therapy
|
Measured by the proportion of subjects who become HEV RNA negative (HEV RNA undetectable)
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after 24 weeks of therapy
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of subjects who are HEV RNA negative 12 weeks after discontinuation of therapy
Time Frame: 12 weeks after discontinuation of therapy (week 36)
|
Viral load measurement
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12 weeks after discontinuation of therapy (week 36)
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Additional efficacy evaluations include HEV RNA change from baseline during therapy
Time Frame: after 2 days, 4 days, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, and 24 weeks of therapy
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Viral load and laboratory measurements
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after 2 days, 4 days, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, and 24 weeks of therapy
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Comparison of proportion of patients who are HEV RNA negative after rapid or slow decline of HEV viral load after 24 weeks of therapy
Time Frame: after 24 weeks of therapy
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Viral load measurement
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after 24 weeks of therapy
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Proportion of subject who reached ALT normalization after 12 weeks and 24 weeks of therapy and 12 weeks after discontinuation of therapy
Time Frame: after 12 and 24 weeks of therapy and 12 weeks after discontinuation of therapy (week 36)
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Laboratory measurement
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after 12 and 24 weeks of therapy and 12 weeks after discontinuation of therapy (week 36)
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Assessment of safety: Adverse events and safety laboratory tests will be collected throughout the study
Time Frame: through study completion, an average of 36 weeks
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Collection of adverse events and safety laboratory tests
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through study completion, an average of 36 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Markus Cornberg, Prof. Dr., Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HepNet-SofE
- 2017-000403-24 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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