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

• Status: Unknown status
• Trial end date: 2019-11-30
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ginkgopharma CO., LTD
• Treatments: Sofosbuvir

Criteria

Inclusion Criteria:

• Hepatitis C virus (HCV) genotype 1 infection (confirmed at screening).

• HCVRNA greater than 10,000 IU/mL at screening.

• Participant must be willing and able to comply with the protocol requirements.

• weight was more than 40 kg.

• age is between 18-75,either sex.

Exclusion Criteria:

• Co-infection with hepatitis B virus or human immunodeficiency virus (HIV).

• Infection with HCV non-genotype 1,or Infection with mixed genotype,or Genotype cannot be confirmed.

• Medical history of major functional organ transplantation.

• Suffering from serious blood system disease(such us Thalassemia/Sickle Cell Anemia).

• Participation in a clinical study within 3 months prior to first dose