Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Acute Hepatitis C
  • Hepatitis C
Type
Interventional
Phase
Phase 2
Design
Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Prospective, open-label, single-arm multicenter, phase II pilot trialMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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.

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.

Tracking Information

NCT #
NCT03818308
Collaborators
  • HepNet Study House, German Liverfoundation
  • Gilead Sciences
  • German Center for Infection Research
Investigators
Principal Investigator: Markus Cornberg, Prof. Dr. Hannover Medical School, Clinic for Gastroenterology, Hepatology, and Endocrinology