NCT04001608

Study of Seraprevir in Combination With Sofosbuvir in Chronic Genotype 1 Hepatitis C Virus Infection Patients

A Phase 3, Multicenter, Open-Label, Single-Arm Study to Investigate the Efficacy and Safety of a 12-Week Regimen of Seraprevir in Combination With Sofosbuvir in Patients With Chronic Genotype 1 Hepatitis C Virus Infection.

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 206 (actual)
• Sponsor: Ginkgopharma CO., LTD · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study was to assess the safety and efficacy of Seraprevir in combination with sofosbuvir administered for 12 weeks in patients with Hepatitis C (HCV) genotype1. Efficacy was assessed by the rate of sustained viral response (SVR) 12 weeks after the discontinuation of therapy (SVR12).

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	Seraprevir	Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
DRUG	Sofosbuvir	Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12

Timeline

• Start date: 2018-10-17
• Primary completion: 2019-07-31
• Completion: 2019-11-30
• First posted: 2019-06-28
• Last updated: 2019-06-28

Locations

22 sites across 1 country: China