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study was not started due to an administrative reason on the part of the local Health Authority
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This open-label, non-comparative study will assess the safety and tolerability of individualized combination therapy with Copegus (ribavirin) and Pegasys (peginterferon alfa-2a) in patients with chronic hepatitis C. Patients with hepatitis C virus (HCV) genotype 1 (Group A) will receive Copegus 1'000 mg or 1'200 mg daily orally for 24-72 weeks. For patients with genotype 2 or 3 HCV (Group B) the Copegus dose will be 800 mg daily for 16-48 weeks. Patients who had previously received standard or pegylated interferons but were non-responders or with relapse (Group C) will receive Copegus 1'000 mg or 1'200 mg daily for up to 72 weeks. Concomitant therapy with Pegasys 180 mcg subcutaneously weekly will be given to all patients. Anticipated time on study treatment is up to 72 weeks with a 24-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental | genotype 1, treatment-naive |
|
| B | Experimental | genotype 2 and 3, treatment-naive |
|
| C | Experimental | all genotypes, non-responders or relapses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc weekly |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of individualized Copegus treatment in combination with Pegasys: Adverse events | up to 96 weeks | |
| Influence of dose reductions in case of adverse events on sustained virological response (HCV-RNA) | up to 96 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Virological response/sustained virological response (serum HCV RNA levels) | 24 weeks after treatment completion |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
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| ribavirin [Copegus] |
| Drug |
1'000/1'200 mg daily orally, 24 - 72 weeks |
|
| ribavirin [Copegus] | Drug | 800 mg daily orally, 16 - 48 weeks |
|
| 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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