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Hepatitis EPhase 2NCT03282474

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

A Phase 2 study testing Sofosbuvir in people with Hepatitis E and Hepatitis Chronic Viral, run by Hannover Medical School at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis E, Hepatitis Chronic Viral
What is being tested?
Sofosbuvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
3 sitesGermany
Study dates
7 Dec 2017to 18 Feb 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

  • Charité, Campus Virchow-Klinikum, Medical Department, Division of Hepatology and Gastroenterology

    Berlin, 13353

  • University Medical Center Hamburg-Eppendorf, Center for Internal Medicine, I. Medical Clinic and Polyclinic

    Hamburg, 20246

  • Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology

    Hanover, Lower Saxony, 30625

Other trials in Germany

About this study

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.

Being tested
Sofosbuvir
Keywords
Hepatitis E
Medical subject headings
Hepatitis E

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SofosbuvirDrug

    Also called Sovaldi

    Sofosbuvir 400 MG Oral Tablet [Sovaldi]

Study groups in NCT03282474
Study groupRoleWhat they receive
SofosbuvirExperimentalSofosbuvir 400 MG film-coated tablet, oral administration of one tablet once daily for 24 weeks.
Receives: Drug: Sofosbuvir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of subjects who become HEV RNA negative after 24 weeks of therapy

    Measured by the proportion of subjects who become HEV RNA negative (HEV RNA undetectable)

    Measured: after 24 weeks of therapy

Secondary outcomes (5)

  1. Proportion of subjects who are HEV RNA negative 12 weeks after discontinuation of therapy

    Viral load measurement

    Measured: 12 weeks after discontinuation of therapy (week 36)

  2. Additional efficacy evaluations include HEV RNA change from baseline during therapy

    Viral load and laboratory measurements

    Measured: after 2 days, 4 days, 1 week, 2 weeks, 4 weeks, 8 weeks, 12 weeks,16 weeks, 20 weeks, and 24 weeks of 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

    Viral load measurement

    Measured: 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

    Laboratory measurement

    Measured: after 12 and 24 weeks of therapy and 12 weeks after discontinuation of therapy (week 36)

  5. Assessment of safety: Adverse events and safety laboratory tests will be collected throughout the study

    Collection of adverse events and safety laboratory tests

    Measured: through study completion, an average of 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2017
  2. Study start7 Dec 2017
  3. Primary completion26 Nov 2018
  4. Study completion18 Feb 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, open-label, single-arm multicenter, phase II pilot trial
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03282474
Sponsor's protocol ID
HepNet-SofE
Other IDs
2017-000403-24, 2017
Status last verified
Mar 2019
First submitted
12 Sep 2017
Last updated
8 Mar 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wahid A, Meyer N, Wundes C, Huffner L, Janshoff S, Frericks N, Friesland M, Dinkelborg K, Aliabadi E, Laue F, Cornberg M, Maasoumy B, Bremer B, Pischke S, Muller T, Wiesch JZS, Benckert J, Ulrich RG, Hardtke S, Dorge P, Vondran F, Lohse A, Manns MP, Todt D, Wedemeyer H, Pietschmann T, Steinmann E, Gomer A, Behrendt P. Extrahepatic Replication and Genomic Signatures of the Hepatitis E Virus in the Kidney. Liver Int. 2025 Jul;45(7):e70183. doi: 10.1111/liv.70183.

    PubMed 40575997

  • Gomer A, Klohn M, Jagst M, Nocke MK, Pischke S, Horvatits T, Schulze Zur Wiesch J, Muller T, Hardtke S, Cornberg M, Wedemeyer H, Behrendt P, Steinmann E, Todt D. Emergence of resistance-associated variants during sofosbuvir treatment in chronically infected hepatitis E patients. Hepatology. 2023 Dec 1;78(6):1882-1895. doi: 10.1097/HEP.0000000000000514. Epub 2023 Jun 20.

    PubMed 37334496

  • Cornberg M, Pischke S, Muller T, Behrendt P, Piecha F, Benckert J, Todt D, Steinmann E, Papkalla A, von Karpowitz M, Koch A, Lohse A, Hardtke S, Manns MP, Wedemeyer H. Sofosbuvir monotherapy fails to achieve HEV RNA elimination in patients with chronic hepatitis E - The HepNet SofE pilot study. J Hepatol. 2020 Sep;73(3):696-699. doi: 10.1016/j.jhep.2020.05.020. Epub 2020 Jul 2. No abstract available.

    PubMed 32624195

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sofosbuvir in people with Hepatitis E and Hepatitis Chronic Viral, run by Hannover Medical School at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 27 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of subjects who become HEV RNA negative after 24 weeks of therapy (time frame: after 24 weeks of therapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03282474, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2019.

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