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

Hepatitis C Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03818308
• Other study ID #: HepNet-aHCV-V
• Secondary ID: 2018-003474-27
• Status: Completed
• Phase: Phase 2
• Start date: May 28, 2019
• Est. completion date: June 8, 2021

Study information

• Verified date: January 2021
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: June 8, 2021
• Est. primary completion date: June 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, a1 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

Related Conditions & MeSH terms

• Acute Hepatitis C
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

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

Locations

Country	Name	City	State
Germany	Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie	Berlin
Germany	Zentrum für Infektiologie Prenzlauer Berg	Berlin
Germany	Allgemeinmedizinische und internistische Praxis	Berlin-Friedrichshain
Germany	Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I	Bonn
Germany	Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie	Essen
Germany	Klinikum der J.W. Goethe-Universität Frankfurt	Frankfurt
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	Hannover
Germany	Praxis Hohenstaufenring	Köln
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

Sponsors (4)

Lead Sponsor	Collaborator
Hannover Medical School	German Center for Infection Research, Gilead Sciences, HepNet Study House, German Liverfoundation

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy
Secondary	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)	after 8 weeks of therapy, and 12 weeks after discontinuation of therapy
Secondary	Assessment of frequency and severity of adverse events (AEs)	Collection of all AEs	through study completion, an average of 20 weeks