Clinical Trials Directory

Trials / Completed

CompletedNCT03818308

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

Multicenter Trial for the Treatment of Acute Hepatitis C for 8 Weeks With Sofosbuvir/Velpatasvir Fix Dose combination_The HepNet Acute HCV-V Study

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
20 (actual)
Sponsor
Hannover Medical School · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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

Interventions

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

Timeline

Start date
2019-05-28
Primary completion
2021-06-08
Completion
2021-06-08
First posted
2019-01-28
Last updated
2021-07-06

Locations

14 sites across 1 country: Germany

Source: ClinicalTrials.gov record NCT03818308. Inclusion in this directory is not an endorsement.