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

NCT ID: NCT01433887

Last Updated: 2014-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-06-30

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.

Detailed Description

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Conditions

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Chronic Hepatitis C

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Genotype 6

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

Group Type EXPERIMENTAL

48-weeks course

Intervention Type DRUG

patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks

Ribavirin

Intervention Type DRUG

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

Genotype 1

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

Group Type EXPERIMENTAL

48-weeks course

Intervention Type DRUG

patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks

Ribavirin

Intervention Type DRUG

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

Genotype 2/3

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

Group Type EXPERIMENTAL

Peginterferon alfa2a

Intervention Type DRUG

patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks

Ribavirin

Intervention Type DRUG

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks

Interventions

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48-weeks course

patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks

Intervention Type DRUG

Ribavirin

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks

Intervention Type DRUG

Peginterferon alfa2a

patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks

Intervention Type DRUG

Ribavirin

patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks

Intervention Type DRUG

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Third Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role lead

Responsible Party

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Cai Qingxian

Sun Yat-Sen University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Eighth People's Hospital of Guangzhou

Guangzhou, Guangdong, China

Site Status

The Third Affliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Zhongshan second people's hospital

Zhongshan, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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TAH5010G6HCV

Identifier Type: -

Identifier Source: org_study_id