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

Sponsor

Hannover Medical School (Other)

Overall Status

Completed

CT.gov ID

NCT03818308

Collaborator

HepNet Study House, German Liverfoundation (Other), Gilead Sciences (Industry), German Center for Infection Research (Other)

Enrollment

Locations

Arm

24.4

Actual Duration (Months)

1.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C Acute Hepatitis C	Drug: Sofosbuvir and Velpatasvir	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Prospective, open-label, single-arm multicenter, phase II pilot trialProspective, open-label, single-arm multicenter, phase II pilot trial

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 28, 2019

Actual Primary Completion Date :

Jun 8, 2021

Actual Study Completion Date :

Jun 8, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Sofosbuvir and Velpatasvir SOF/VEL FDC film-coated tablet, oral, SOF 400 mg/VEL 100 mg daily, 8 weeks	Drug: Sofosbuvir and Velpatasvir All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks. Other Names: Epclusa 400 mg/100 mg film-coated tablets

Arm

Intervention/Treatment

Experimental: Sofosbuvir and Velpatasvir

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

Drug: Sofosbuvir and Velpatasvir

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

Other Names:

Epclusa 400 mg/100 mg film-coated tablets

Outcome Measures

Primary Outcome Measures

Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy [12 weeks after discontinuation of therapy]
Measured by the portion of subjects with sustained virological response (undetectable HCV RNA)

Secondary Outcome Measures

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]
Measured by mean HCV RNA viral load
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]
Measured by the proportion of subjects who reached ALT normalization (ALT < ULN)
Assessment of frequency and severity of adverse events (AEs) [through study completion, an average of 20 weeks]
Collection of all AEs

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Allgemeinmedizinische und internistische Praxis	Berlin-Friedrichshain	Germany	10243
2	Zentrum für Infektiologie Prenzlauer Berg	Berlin	Germany	10349
3	Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie	Berlin	Germany	13353
4	Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I	Bonn	Germany	53127
5	Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie	Essen	Germany	45122
6	Klinikum der J.W. Goethe-Universität Frankfurt	Frankfurt	Germany	60590
7	Infektionsmedizinisches Centrum Hamburg (ICH) Study Center	Hamburg	Germany	20146
8	Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik	Hamburg	Germany	20246
9	Medizinische Hochschule Hannover, Innere Medizin, Klinik für Gastroenterologie, Hepatologie und Endokrinologie	Hannover	Germany	30625
10	Praxis Hohenstaufenring	Köln	Germany	50674
11	Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie	Leipzig	Germany	04103
12	Klinikum rechts der Isar der TU-München, II Medizinische Klinik und Poliklinik	München	Germany	81675
13	Gemeinschaftspraxis - Infectomed	Stuttgart	Germany	70197
14	Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie	Würzburg	Germany	97080