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

Sun Yat-sen University

Status and phase: Completed; Phase 3

Conditions: Chronic Hepatitis C

Treatments: Drug: Ribavirin; Drug: 48-weeks course; Drug: Peginterferon alfa2a

Study type: Interventional

Funder types: Other

Identifiers

NCT01433887

TAH5010G6HCV

Details and patient eligibility

About

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.

Enrollment: 535 patients

Sex: All

Ages: 16 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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535 participants in 3 patient groups

Genotype 6

Experimental group

Description:

Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks

Treatment:

Drug: Ribavirin

Drug: 48-weeks course

Drug: Ribavirin

Genotype 1

Experimental group

Description:

Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks

Treatment:

Drug: Ribavirin

Drug: 48-weeks course

Drug: Ribavirin

Genotype 2/3

Experimental group

Description:

Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks

Treatment:

Drug: Ribavirin

Drug: Peginterferon alfa2a

Drug: Ribavirin