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HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03282474
Recruitment Status : Completed
First Posted : September 14, 2017
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
HepNet Study House, German Liverfoundation
Gilead Sciences
German Center for Infection Research
Information provided by (Responsible Party):
Hannover Medical School

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
Hepatitis E Hepatitis Chronic Viral Drug: Sofosbuvir Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective, open-label, single-arm multicenter, phase II pilot trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: HepNet Pilot Trial: Multicenter Trial for the Treatment of Chronic Hepatitis E With Sofosbuvir (SofE)
Actual Study Start Date : December 7, 2017
Actual Primary Completion Date : November 26, 2018
Actual Study Completion Date : February 18, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Sofosbuvir

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 Name: Sovaldi




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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

  2. 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 ]
    Viral load and laboratory measurements

  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 [ Time Frame: after 24 weeks of therapy ]
    Viral load measurement

  4. 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) ]
    Laboratory measurement

  5. 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 ]
    Collection of adverse events and safety laboratory tests



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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 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.
  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/Day1 visit.

  11. Known hypersensitivity to SOF or formulation excipients.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03282474


Locations
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Germany
Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
Hanover, Lower Saxony, Germany, 30625
Charité, Campus Virchow-Klinikum, Medical Department, Division of Hepatology and Gastroenterology
Berlin, Germany, 13353
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
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Principal Investigator: Markus Cornberg, Prof. Dr. Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology

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Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT03282474    
Other Study ID Numbers: HepNet-SofE
2017-000403-24 ( EudraCT Number )
First Posted: September 14, 2017    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Hannover Medical School:
Hepatitis E
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis E
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Sofosbuvir
Antiviral Agents
Anti-Infective Agents