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

Ginkgo Pharma

Status and phase: Unknown; Phase 3

Conditions: Hepatitis C Virus Infection

Treatments: Drug: Sofosbuvir; Drug: Seraprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT04001608

GP205-1801

Details and patient eligibility

About

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).

Enrollment: 206 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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206 participants in 1 patient group

Seraprevir and sofosbuvir

Experimental group

Description:

Subjects will receive oral tablets of Seraprevir 100mg twice a day along with oral tablet of sofosbuvir 400 mg,once a day from Day 1 up to Week 12.

Treatment:

Drug: Seraprevir

Drug: Sofosbuvir