Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic Hepatitis C Genotypes 1 Versus 2/3 Versus 6
This study is currently recruiting participants.
Verified February 2013 by Third Affiliated Hospital, Sun Yat-Sen University
Sponsor:
Third Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov Identifier:
NCT01433887
First received: September 11, 2011
Last updated: February 20, 2013
Last verified: February 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C |
Drug: 48-weeks course Drug: Ribavirin Drug: Peginterferon alfa2a |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Response to Pegylated Interferon and Ribavirin in Chinese Patients With Chronic |
Resource links provided by NLM:
Further study details as provided by Third Affiliated Hospital, Sun Yat-Sen University:
Primary Outcome Measures:
- Sustained virological response (SVR) [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment
Secondary Outcome Measures:
- Change in health related quality as measured by short form 36 (SF-36) from baseline to 24 weeks after the end of treatment [ Time Frame: 24 weeks after the end of treatment ] [ Designated as safety issue: No ]
- Sick leave in patients treated for 24 or 48 weeks treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 500 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2013 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Genotype 6
Genotype 6 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
|
Drug: 48-weeks course
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
Drug: Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
|
|
Experimental: Genotype 1
Genotype 1 chronic hepatitis C patients will be treated with Peginterferon alfa-2a plus ribavirin for 48 weeks
|
Drug: 48-weeks course
patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
Drug: Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
|
|
Experimental: Genotype 2/3
Genotype 2/3 chronic hepatitis C patients will be treated with Peginterferon alfa-2a/2b plus ribavirin for 24 weeks
|
Drug: Peginterferon alfa2a
patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
Drug: Ribavirin
patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
|
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433887
Contacts
| Contact: Cai Qingxian, doctor | +86013760857996 | cqx200000@163.com |
| Contact: Zhao Zhixin, doctor | +86013527873716 | zxzhao@21cn.com |
Locations
| China, Guangdong | |
| The Third Affliated Hospital of Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China, 510630 | |
| Contact: Cai Qingxian, Doctor +86013760857996 Cqx200000@163.com | |
| Principal Investigator: Zhang Xiaohong, Doctor | |
| Sub-Investigator: Lin Chaoshuang, Doctor | |
| Zhongshan second people's hospital | Recruiting |
| Zhongshan, Guangdong, China | |
| Contact: Wei min, Doctor +86013702528182 | |
| Principal Investigator: Wei min, Doctor | |
Sponsors and Collaborators
Third Affiliated Hospital, Sun Yat-Sen University
More Information
No publications provided
| Responsible Party: | Cai Qingxian, Sun Yat-Sen University, Third Affiliated Hospital, Sun Yat-Sen University |
| ClinicalTrials.gov Identifier: | NCT01433887 History of Changes |
| Other Study ID Numbers: | TAH5010G6HCV |
| Study First Received: | September 11, 2011 |
| Last Updated: | February 20, 2013 |
| Health Authority: | China: Food and Drug Administration |
Keywords provided by Third Affiliated Hospital, Sun Yat-Sen University:
|
Peginterferon alfa-2a ribavirin |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis, Chronic Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
Interferons Ribavirin Peginterferon alfa-2a Interferon-alpha Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013