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Hepatitis CPhase 2NCT03818308

Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir

A Phase 2 study testing Sofosbuvir and Velpatasvir in people with Hepatitis C and Acute Hepatitis C, run by Hannover Medical School at 14 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 evaluate the efficacy and safety of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute hepatitis C virus (HCV) infection. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Acute Hepatitis C
What is being tested?
Sofosbuvir and Velpatasvir
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
14 sitesGermany
Study dates
28 May 2019to 8 Jun 2021
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
  • HCV RNA > 10^3 IU/mL at screening
  • Confirmation of acute HCV infection documented by either:
  • Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening
  • Documented conversion to HCV RNA positivity within the 4 months preceding screening
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  • or known or suspected exposure to HCV within the 4 months preceding screening with 10 times elevated serum ALT level at screening or 4 month preceding screening without evidence of confounding liver disorders
  • Body mass index (BMI) ≥18 kg/m2
  • Subjects must have the following laboratory parameters at screening:
  • INR ≤ 1.5 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)
  • 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 the end of follow up:
  • 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

  • Subject has been treated with any investigational drug or device within 42 days of the Screening visit
  • Co-Infection with HIV
  • Clinically-significant illness (other than HCV) or any other major medical disorder that, in the opinion of the investigator, may interfere with subject treatment, assessment or compliance with the protocol.
  • Solid organ transplantation
  • Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).
  • Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).
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  • 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 well-controlled 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 that significantly impairs patient compliance. Uncontrolled users of intravenous drugs will not be permitted to enroll in the study.
  • Clinical relevant (not controlled) liver disease of a non-HCV etiology (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, Wilson's disease, α1 antitrypsin deficiency, cholangitis)
  • Use of any prohibited concomitant medications within 21 days before the Baseline/Day 1 visit. The use of amiodarone is prohibited from 60 days prior to Day 1 through the end of treatment;
  • Known hypersensitivity to SOF/VEL or formulation excipients

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Germany14 sites

  • Zentrum für Infektiologie Prenzlauer Berg

    Berlin, 10349

  • Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie

    Berlin, 13353

  • Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

    Bonn, 53127

  • Praxis Hohenstaufenring

    Cologne, 50674

  • Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie

    Essen, 45122

  • Klinikum der J.W. Goethe-Universität Frankfurt

    Frankfurt, 60590

  • Allgemeinmedizinische und internistische Praxis

    Friedrichshain, 10243

  • Infektionsmedizinisches Centrum Hamburg (ICH) Study Center

    Hamburg, 20146

  • Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik

    Hamburg, 20246

  • Medizinische Hochschule Hannover, Innere Medizin, Klinik für Gastroenterologie, Hepatologie und Endokrinologie

    Hanover, 30625

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie

    Leipzig, 04103

  • Klinikum rechts der Isar der TU-München, II Medizinische Klinik und Poliklinik

    München, 81675

  • Gemeinschaftspraxis - Infectomed

    Stuttgart, 70197

  • Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie

    Würzburg, 97080

Other trials in Germany

About this study

Official title: Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study

This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with sofosbuvir (SOF)/velpatasvir (VEL) fix dose combination (FDC) in patients with acute hepatitis C virus (HCV) infection.

Read the detailed description

This is a single arm multicenter pilot study to evaluate the efficacy and safety of treatment with SOF/VEL FDC for 8 weeks in patients with acute HCV infection as measured by the proportion of subjects with sustained viral response (undetectable HCV RNA) 12 weeks after stop of therapy.

Being tested
Sofosbuvir and Velpatasvir
Keywords
Acute hepatitis C virus (HCV) infection
Medical subject headings
Hepatitis C, Infections

What participants receive

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

  • Sofosbuvir and VelpatasvirDrug

    Also called Epclusa 400 mg/100 mg film-coated tablets

    All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks.

Study groups in NCT03818308
Study groupRoleWhat they receive
Sofosbuvir and VelpatasvirExperimentalSOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks
Receives: Drug: Sofosbuvir and Velpatasvir

What is being measured

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

  1. Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy

    Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)

    Measured: 12 weeks after discontinuation of therapy

Secondary outcomes (3)

  1. Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy

    Measured by mean HCV RNA viral load

    Measured: at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy

  2. Proportion of subjects who reached ALT normalization (ALT < ULN) after 8 weeks of therapy and 12 weeks after discontinuation of therapy

    Measured by the proportion of subjects who reached ALT normalization (ALT < ULN)

    Measured: after 8 weeks of therapy, and 12 weeks after discontinuation of therapy

  3. Assessment of frequency and severity of adverse events (AEs)

    Collection of all AEs

    Measured: through study completion, an average of 20 weeks

Timeline

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

  1. First posted28 Jan 2019
  2. Study start28 May 2019
  3. Primary completion8 Jun 2021
  4. Study completion8 Jun 2021

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
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03818308
Sponsor's protocol ID
HepNet-aHCV-V
Other IDs
2018-003474-27, 2018
Status last verified
Jan 2021
First submitted
24 Jan 2019
Last updated
6 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maasoumy B, Ingiliz P, Spinner CD, Cordes C, Stellbrink HJ, Schulze Zur Wiesch J, Schneeweiss SM, Deterding K, Muller T, Kahlhofer J, Dorge P, von Karpowitz M, Manns MP, Wedemeyer H, Cornberg M; HepNet Acute HCV-V Study Group. Sofosbuvir plus velpatasvir for 8 weeks in patients with acute hepatitis C: The HepNet acute HCV-V study. JHEP Rep. 2022 Dec 16;5(3):100650. doi: 10.1016/j.jhepr.2022.100650. eCollection 2023 Mar.

    PubMed 36852107

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sofosbuvir and Velpatasvir in people with Hepatitis C and Acute Hepatitis C, run by Hannover Medical School at 14 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 26 inclusion and 14 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 6 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 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 with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy (time frame: 12 weeks after discontinuation 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 NCT03818308, which also lists 1 linked publication.

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 6 Jul 2021.

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