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

NCT03818308 | Completed Phase 2

• 2 other identifiers: HepNet-aHCV-V2018-003474-27
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 14

Brief 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.

Conditions

Hepatitis C; Acute Hepatitis C

Keywords

Acute hepatitis C virus (HCV) infection

Outcome Measures

Primary Outcomes (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)

  12 weeks after discontinuation of therapy

Secondary Outcomes (3)

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

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

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

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

• Assessment of frequency and severity of adverse events (AEs)

  through study completion, an average of 20 weeks

Study Arms (1)

Sofosbuvir and Velpatasvir

EXPERIMENTAL

SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks

Drug: Sofosbuvir and Velpatasvir

Interventions

Sofosbuvir and Velpatasvir DRUG

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

Also known as: Epclusa 400 mg/100 mg film-coated tablets

Sofosbuvir and Velpatasvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.
• 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

You may not qualify if:

• 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).
• 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

Sponsors & Collaborators

• Hannover Medical School: lead
• HepNet Study House, German Liverfoundation: collaborator
• Gilead Sciences: collaborator
• German Center for Infection Research: collaborator

Study Sites (14)

Zentrum für Infektiologie Prenzlauer Berg

Berlin, 10349, Germany

Location

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

Berlin, 13353, Germany

Location

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

Bonn, 53127, Germany

Location

Praxis Hohenstaufenring

Cologne, 50674, Germany

Location

Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie

Essen, 45122, Germany

Location

Klinikum der J.W. Goethe-Universität Frankfurt

Frankfurt, 60590, Germany

Location

Allgemeinmedizinische und internistische Praxis

Friedrichshain, 10243, Germany

Location

Infektionsmedizinisches Centrum Hamburg (ICH) Study Center

Hamburg, 20146, Germany

Location

Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik

Hamburg, 20246, Germany

Location

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

Hanover, 30625, Germany

Location

Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie

Leipzig, 04103, Germany

Location

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

München, 81675, Germany

Location

Gemeinschaftspraxis - Infectomed

Stuttgart, 70197, Germany

Location

Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie

Würzburg, 97080, Germany

Location

Related Publications (1)

• 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.

  PMID: 36852107 DERIVED

MeSH Terms

Conditions

Hepatitis C; Infections

Interventions

sofosbuvir-velpatasvir drug combination

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Markus Cornberg, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, open-label, single-arm multicenter, phase II pilot trial

Study Record Dates

• First Submitted: January 24, 2019
• First Posted: January 28, 2019
• Study Start: May 28, 2019
• Primary Completion: June 8, 2021
• Study Completion: June 8, 2021
• Last Updated: July 6, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (14)