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

Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01433887
Enrollment
535
Registered
2011-09-14
Start date
2011-11-30
Completion date
2014-06-30
Last updated
2014-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis C

Keywords

Peginterferon alfa-2a, ribavirin

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.

Interventions

DRUG48-weeks course

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

DRUGRibavirin

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

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

Sponsors

Third Affiliated Hospital, Sun Yat-Sen University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Sustained virological response (SVR)24 weeks after the end of treatmentUndetectable HCVRNA in serum(\<15IU/ml) 24 weeks after the end of treatment

Secondary

MeasureTime frame
Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment24 weeks after the end of treatment
Sick leave in patients treated for 24 or 48 weeks treatment48 weeks

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026