A Randomized Trial of 24-Week Versus 48-Week Courses of Peginterferon Plus Ribavirin for Patients With Genotype 1 Hepatitis C and IL28B CC Polymorphism
This study is currently recruiting participants.
Verified May 2012 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:
NCT01441804
First received: September 24, 2011
Last updated: May 20, 2012
Last verified: May 2012
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Purpose
Patients with HCV genotype 1 and IL28B CC Polymorphism who have a rapid virological response to treatment are randomised to either 24 or 48 weeks HCV treatment. Our hypothesis is that there is no important difference in effect between the two treatment effect.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis C |
Drug: Peginterferon alfa2a Drug: Ribavirin |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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 from 36 (SF-36) from baseline to 24 weeks after the end of treatment [ Time Frame: baseline, 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: | 200 |
| Study Start Date: | May 2011 |
| Estimated Study Completion Date: | August 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 24-Week treatment group
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 20 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
|
|
Active Comparator: 48-Week treatment group
Genotype 1 chronic hepatitis C patients with IL28B CC Polymorphism and rapid virological response(undetectable HCV RNA at weeks 4) in this group will be treated with Peginterferon alfa-2a plus ribavirin for an additional 44 weeks
|
Drug: Peginterferon alfa2a
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
|
Eligibility| Ages Eligible for Study: | 16 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Age > 18 years
- Serum Hepatitis C RNA > 10,000IU/mL
- Hepatitis C virus genotype 1
- IL28B CC polymorphism
Exclusion Criteria:
- Previous treatment for chronic Hepatitis C
- clinical or biological evidence of acute hepatitis, including serum ALT or AST > 300U/ml
- HIV antibody positive, hepatitis b surface antigen positive or known diagnosis of other chronic liver disease
Contraindications to PR-based treatment:
- Uncontrolled psychiatric illness
- Active substance dependency
- Known autoimmune disorder
- Untreated thyroid disease
- Uncontrolled seizure disorder
- Pregnancy, lactation or inability to maintain contraception
- Chronic kidney disease w/ estimated GFR< 60
- ANC<1.5/nl, Hb<12g/dl, or platelets<75/nl
Clinical or biochemical evidence of decompensated liver disease including:
- History of encephalopathy
- Ascites
- Variceal bleeding
- Bilirubin > 3g/dl or INR > 1.5
- Life threatening disorder with expected median survival less than 5 years
- Inability to comply with drug regimens or testing schedule required for study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441804
Contacts
| Contact: Cai Qingxian, doctor | +86013760857996 | cqx200000@163.com |
| Contact: Zhao Zhixin, doctor | +86013527873714 | zxzhao@21cn.com |
Locations
| China, Guangdong | |
| The Third Affliated Hospital of Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China, 510630 | |
| Contact: Cai Qingxian, doctor 13760857996 Cqx200000@163.com | |
| Principal Investigator: Zhang Xiaohong, Doctor | |
| Sub-Investigator: Lin Chaoshuang, doctor | |
| The Eighth People's Hospital of Guangzhou | Recruiting |
| Guangzhou, Guangdong, China, 510630 | |
| Contact: Chen Fengjuan, Doctor 13416167557 fengjuandj@163.com | |
| Principal Investigator: Xu Min, doctor | |
| Panyu People's Hospital | Recruiting |
| Guangzhou, Guangdong, China | |
| Contact: Huang mingshou , Bachelor +86013711033556 | |
| Principal Investigator: Huang mingshou, Bachelor | |
| 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
Investigators
| Study Chair: | Gao Zhiliang, Doctor | The Third Affliated Hospital of Sun Yat-sen University |
| Study Director: | Zhao Zhixin, Doctor | The Third Affliated Hospital of Sun Yat-sen University |
| Principal Investigator: | Zhang Xiaohong, Doctor | The Third Affliated Hospital of Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | Cai Qingxian, Third Affiliated Hospital, Sun Yat-Sen University |
| ClinicalTrials.gov Identifier: | NCT01441804 History of Changes |
| Other Study ID Numbers: | TAHG1IL-28BCC |
| Study First Received: | September 24, 2011 |
| Last Updated: | May 20, 2012 |
| Health Authority: | China: Food and Drug Administration |
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 Ribavirin Peginterferon alfa-2a Interferon-alpha Antiviral Agents Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 19, 2013