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

NCT ID: NCT03818308

Last Updated: 2021-07-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-28
• Study Completion Date: 2021-06-08

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.

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.

Conditions

Hepatitis C; Acute Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sofosbuvir and Velpatasvir

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

Group Type: EXPERIMENTAL

Sofosbuvir and Velpatasvir

Intervention Type: DRUG

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

Interventions

Sofosbuvir and Velpatasvir

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

Intervention Type: DRUG

Other Intervention Names

Epclusa 400 mg/100 mg film-coated tablets

Eligibility Criteria

Inclusion Criteria

1. Willing and able to provide written informed consent

2. Male or female, age > 18 years

3. HCV RNA > 10^3 IU/mL at screening

4. Confirmation of acute HCV infection documented by either:

1. Documented seroconversion to HCV antibody (anti-HCV) positivity within the 4 months preceding screening

2. Documented conversion to HCV RNA positivity within the 4 months preceding screening

3. 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

5. Body mass index (BMI) ≥18 kg/m2

6. Subjects must have the following laboratory parameters at screening:

1. INR ≤ 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR

2. HbA1c ≤ 10%

3. Creatinine clearance (CLcr) ≥ 30 mL/min, as calculated by the Cockcroft-Gault equation (using actual body weight)

7. 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

8. 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. Subject has been treated with any investigational drug or device within 42 days of the Screening visit

2. Co-Infection with HIV

3. 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.

4. Solid organ transplantation

5. Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug (for example, gastric bypass or severe ulcerative colitis).

6. Clinical signs of hepatic decompensation (i.e., clinical ascites, encephalopathy or variceal hemorrhage).

7. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.

8. 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.

9. Significant drug allergy (such as anaphylaxis or hepatotoxicity).

10. Pregnant or nursing female

11. 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.

12. 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)

13. 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;

14. Known hypersensitivity to SOF/VEL or formulation excipients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HepNet Study House, German Liverfoundation

NETWORK

Sponsor Role: collaborator

Gilead Sciences

INDUSTRY

Sponsor Role: collaborator

German Center for Infection Research

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Markus Cornberg, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Zentrum für Infektiologie Prenzlauer Berg

Berlin, , Germany

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

Berlin, , Germany

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I

Bonn, , Germany

Praxis Hohenstaufenring

Cologne, , Germany

Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie

Essen, , Germany

Klinikum der J.W. Goethe-Universität Frankfurt

Frankfurt, , Germany

Allgemeinmedizinische und internistische Praxis

Friedrichshain, , Germany

Infektionsmedizinisches Centrum Hamburg (ICH) Study Center

Hamburg, , Germany

Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik

Hamburg, , Germany

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

Hanover, , Germany

Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie

Leipzig, , Germany

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

München, , Germany

Gemeinschaftspraxis - Infectomed

Stuttgart, , Germany

Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie

Würzburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 36852107 (View on PubMed)

Other Identifiers

2018-003474-27

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

HepNet-aHCV-V

Identifier Type: -

Identifier Source: org_study_id