Trial | NCT04001608  Report issue

Title

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.

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    206
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).
Study Started
Oct 17
2018
Primary Completion
Jul 31
2019
Anticipated
Study Completion
Nov 30
2019
Anticipated
Last Update
Jun 28
2019

Drug Seraprevir

Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12

  • Other names: GP205

Drug Sofosbuvir

Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12

  • Other names: sovaldi

Seraprevir and sofosbuvir Experimental

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.

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
No Results Posted