Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6
1 other identifier
interventional
535
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2011
Typical duration for phase_3
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 11, 2011
CompletedFirst Posted
Study publicly available on registry
September 14, 2011
CompletedStudy Start
First participant enrolled
November 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedNovember 18, 2014
November 1, 2014
2.6 years
September 11, 2011
November 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
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
Study Arms (3)
Genotype 6
EXPERIMENTALGenotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
Genotype 1
EXPERIMENTALGenotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
Genotype 2/3
EXPERIMENTALGenotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks
Interventions
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
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
Eligibility Criteria
You may qualify if:
- HCV RNA is positive
- Treatment naive
- Come from China
You may not qualify if:
- Active substance abuse
- Poorly controlled psychiatric disease
- HBsAg positive
- Anti-HIV positive
- Suffering from other significant concurrent medical conditions including chronic liver diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
The Eighth People's Hospital of Guangzhou
Guangzhou, Guangdong, 510000, China
The Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630, China
Zhongshan second people's hospital
Zhongshan, Guangdong, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Sun Yat-Sen University
Study Record Dates
First Submitted
September 11, 2011
First Posted
September 14, 2011
Study Start
November 1, 2011
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
November 18, 2014
Record last verified: 2014-11