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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 24-Week treatment group | Experimental | 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 |
|
| 48-Week treatment group | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peginterferon alfa2a | Drug | patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response (SVR) | Undetectable HCVRNA in serum(<15IU/ml) 24 weeks after the end of treatment | 24 weeks after the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in health related quality as measured by short from 36 (SF-36) from baseline to 24 weeks after the end of treatment | baseline, 24 weeks after the end of treatment | |
| Sick leave in patients treated for 24 or 48 weeks treatment | 48 weeks |
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Inclusion Criteria:
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:
Clinical or biochemical evidence of decompensated liver disease including:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Cai Qingxian, doctor | Contact | +86013760857996 | cqx200000@163.com | |
| Zhao Zhixin, doctor | Contact | +86013527873714 | zxzhao@21cn.com |
| Name | Affiliation | Role |
|---|---|---|
| Gao Zhiliang, Doctor | The Third Affliated Hospital of Sun Yat-sen University | Study Chair |
| Zhao Zhixin, Doctor | The Third Affliated Hospital of Sun Yat-sen University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eighth People's Hospital of Guangzhou | Recruiting | Guangzhou | Guangdong | 510630 | China |
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| Ribavirin | Drug | patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks |
|
| Peginterferon alfa2a | Drug | patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks |
|
| Ribavirin | Drug | patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks |
|
| Zhang Xiaohong, Doctor |
| The Third Affliated Hospital of Sun Yat-sen University |
| Principal Investigator |
| The Third Affliated Hospital of Sun Yat-sen University | Recruiting | Guangzhou | Guangdong | 510630 | China |
|
| Panyu People's Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| Zhongshan second people's hospital | Recruiting | Zhongshan | Guangdong | China |
|
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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