Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6

Study Overview
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Brief Summary
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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.

Official Title
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Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: 48-weeks course
* Drug: Ribavirin
* Drug: Peginterferon alfa2a
* Drug: Ribavirin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Genotype 6<br>Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks | Drug: 48-weeks course<br>* patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks<br>Drug: Ribavirin<br>* patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks<br>|
| Experimental: Genotype 1<br>Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks | Drug: 48-weeks course<br>* patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks<br>Drug: Ribavirin<br>* patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks<br>|
| Experimental: Genotype 2/3<br>Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks | Drug: Peginterferon alfa2a<br>* patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks<br>Drug: Ribavirin<br>* patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained virological response (SVR) | Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment | 24 weeks after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Sick leave in patients treated for 24 or 48 weeks treatment |  | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peginterferon alfa-2a, ribavirin