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This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients with compensated LC.
Additionally, this study evaluated the dosage reactivity and the pharmacokinetic characteristics of the combination therapy of peginterferon alfa-2a and ribavirin in CHC patients with compensated LC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a 180μg | Drug | 180μg(s.c.)/week for 48 weeks |
| |
| peginterferon alfa-2a 90μg |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response, defined as undetectable hepatitis C virus (HCV)-RNA (< 50 IU per milliliter [IU/mL]) | week 24 from the end of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemical response (normalization of serum alanine aminotransferase activity) | at the end of treatment and week 24 form the end of treatment | |
| Virological response (HCV-RNA < 50 IU per milliliter) | at the end of treatment and week 24 form the end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Takehiko Aoshima | Clinical Research Department 4, Chugai Pharmaceutical Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chugoku | Chugoku | Japan | ||||
| Hokkaido Region |
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| Drug |
90μg(s.c.)/week for 48 weeks |
|
| ribavirin | Drug | 600, 800, or 1,000 mg X 2(p.o.)/day |
|
| Hokkaido |
| Japan |
| Kanto Region | Kanto | Japan |
| Kinki Region | Kinki | Japan |
| Kyusyu Region | Kyusyu | Japan |
| Shikoku Region | Shikoku | Japan |
| Tohoku Region | Tōhoku | Japan |
| Tokai Region | Tōkai | Japan |
| ID | Term |
|---|---|
| D008103 | Liver Cirrhosis |
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
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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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