Clinical trial NCT03818308: Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C
Acute Hepatitis C
Keywords: Acute hepatitis C virus (HCV) infection
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: HepNet Study House, German Liverfoundation
name: Gilead Sciences
name: German Center for Infection Research
First posted: 2019-01-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, open-label, single-arm multicenter, phase II pilot trial
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Proportion of subjects with sustained virological response (undetectable HCV RNA) 12 weeks after discontinuation of therapy
timeFrame: 12 weeks after discontinuation of therapy
Secondary outcomes:
measure: Mean HCV RNA viral load at baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks after stop of therapy
timeFrame: at baseline, after 2 weeks, 4 weeks and 8 weeks of therapy, and 12 weeks after stop of therapy
measure: Proportion of subjects who reached ALT normalization (ALT < ULN) after 8 weeks of therapy and 12 weeks after discontinuation of therapy
timeFrame: after 8 weeks of therapy, and 12 weeks after discontinuation of therapy
measure: Assessment of frequency and severity of adverse events (AEs)
timeFrame: through study completion, an average of 20 weeks
Other outcomes:
Locations:
city: Berlin-Friedrichshain
country: Germany
facility: Allgemeinmedizinische und internistische Praxis
city: Berlin
country: Germany
facility: Zentrum für Infektiologie Prenzlauer Berg
city: Berlin
country: Germany
facility: Charité Campus Virchow-Klinikum, Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik I
city: Essen
country: Germany
facility: Universitätsklinikum Essen, Klinik für Gastroenterologie und Hepatologie
city: Frankfurt
country: Germany
facility: Klinikum der J.W. Goethe-Universität Frankfurt
city: Hamburg
country: Germany
facility: Infektionsmedizinisches Centrum Hamburg (ICH) Study Center
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf, I. Medizinische Klinik und Poliklinik
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover, Innere Medizin, Klinik für Gastroenterologie, Hepatologie und Endokrinologie
city: Köln
country: Germany
facility: Praxis Hohenstaufenring
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig, Klinik und Poliklinik für Gastroenterologie
city: München
country: Germany
facility: Klinikum rechts der Isar der TU-München, II Medizinische Klinik und Poliklinik
city: Stuttgart
country: Germany
facility: Gemeinschaftspraxis - Infectomed
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg, Medizinische Klinik II, Schwerpunkt Infektiologie
Study officials:
affiliation: Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology
name: Markus Cornberg, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: