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The purposes of this study are:
The aims of the present study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Peg-interferon alpha-2a & Ribavirin | Active Comparator | Arm A: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks. |
|
| B: Peg-interferon alpha-2a & Ribavirin | Experimental | Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks. (Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1) |
|
| C: Peg-interferon alpha-2a & Ribavirin | Experimental | Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. (Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1) |
|
| D: Peg-interferon alpha-2a & Ribavirin | Active Comparator | Arm D: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. (Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment) |
|
| E: Peg-interferon alpha-2a & Ribavirin | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A: Peg-interferon alpha-2a & Ribavirin | Drug | Arm A: Patients who have low viral loads (LVL, defined as baseline HCV RNA < 400,000 IU/mL) and RVR will be treated with PEGASYS 180ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4 Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period | 24-week off-treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | adverse event rate and profile | 24-week off-treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chia-Yen Dai, M.D., PhD. | Kaohsiung Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kaohsiung Medical University Hospital | Kaohsiung City | Taiwan |
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Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. (Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F a ratio of 1:1) |
|
| F: Peg-interferon alpha-2a & Ribavirin | Experimental | Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks. (Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F a ratio of 1:1) |
|
|
| B: Peg-interferon alpha-2a & Ribavirin | Drug | Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1. Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks. |
|
|
| C: Peg-interferon alpha-2a & Ribavirin | Drug | Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1. Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. |
|
|
| D: Peg-interferon alpha-2a & Ribavirin | Drug | Arm D: Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment will be treated with PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. |
|
|
| E: Peg-interferon alpha-2a & Ribavirin | Drug | Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1. Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks. |
|
|
| F: Peg-interferon alpha-2a & Ribavirin | Drug | Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1. Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks. |
|
|
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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