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The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL).
In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Interferon (IFN)-Treated |
|
| 2 | Experimental | Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1 |
|
| 3 | Experimental | Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1 |
|
| 4 | Experimental | Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pegasys® | Drug | 180μg for s.c./week for 48 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained viral response as undetectable level of HCV-RNA | week 24 from the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical response as normal level of ALT | week 24 from the end of treatment | |
| Viral response as undetectable level of HCV-RNA | at the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ken Kashima | Chugai Pharmaceutical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kyusyu Region | Fukuoka | Japan | ||||
| Chugoku Region |
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| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
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| Pegasys® |
| Drug |
180μg for s.c./week for 24 weeks |
|
| Okayama |
| Japan |
| Kinki Region | Osaka | Japan |
| Hokkaido Region | Sapporo | Japan |
| Kanto Region | Tokyo | Japan |
| Tokai Region | Yamanashi | Japan |
| 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 |