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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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