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

Ginkgopharma CO., LTD206 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

206

Conditions

Hepatitis C Virus Infection

Interventions

SeraprevirDRUG

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

SofosbuvirDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (22)

Beijing Ditan Hospital,Capital Medical University

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Actual End of Treatment（SVR12）

SVR12 is defined as HCV RNA \< the lower limit of quantification (LLOQ; ie, \< 15 IU/mL) 12 weeks following the last dose of study drug.

Time frame: Posttreatment Week 12

Secondary Outcomes

Percentage of Participants Achieving a Sustained Virologic Response 4 Weeks After the Actual End of Treatment (SVR4)

SVR4 is defined as HCV RNA \< LLOQ at 4 weeks following the last dose of study drug.

Time frame: Posttreatment Week 4

Percentage of Participants Achieving a On-treatment Virologic Response

Percentage of participants who achieved HCV RNA \<LLOQ at week 1,week 2,week 4,week8,week 12.

Time frame: week 1,week 2,week 4,week8,week 12

Data from ClinicalTrials.gov

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