Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6
Phase 3
Completed
- Conditions
- Chronic Hepatitis C
- Interventions
- Registration Number
- NCT01433887
- Lead Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Brief Summary
The Chinese patients with chronic hepatitis C have a different genetic background, which had been demonstrated to significantly influence their responses to pegylated interferon and ribavirin. In this study, Chinese patients with Hepatitis C Virus genotype 1, 2/3, 6 infection were treated with pegylated interferon and ribavirin. Their response was compared amongst different genotypes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 535
Inclusion Criteria
- HCV RNA is positive
- Treatment naive
- Come from China
Exclusion Criteria
- Active substance abuse
- Poorly controlled psychiatric disease
- HBsAg positive
- Anti-HIV positive
- Suffering from other significant concurrent medical conditions including chronic liver diseases
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Genotype 6 48-weeks course Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks Genotype 2/3 Peginterferon alfa2a Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks Genotype 1 48-weeks course Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks Genotype 6 Ribavirin Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks Genotype 1 Ribavirin Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks Genotype 2/3 Ribavirin Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks
- Primary Outcome Measures
Name Time Method Sustained virological response (SVR) 24 weeks after the end of treatment Undetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment
- Secondary Outcome Measures
Name Time Method Sick leave in patients treated for 24 or 48 weeks treatment 48 weeks Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment 24 weeks after the end of treatment
Trial Locations
- Locations (3)
The Eighth People's Hospital of Guangzhou
🇨🇳Guangzhou, Guangdong, China
The Third Affliated Hospital of Sun Yat-sen University
🇨🇳Guangzhou, Guangdong, China
Zhongshan second people's hospital
🇨🇳Zhongshan, Guangdong, China