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This 2 arm open-label study will assess the safety and tolerability of combination treatment with Peginterferon alfa (Pegasys) and Ribavirin (Copegus) in patients with chronic hepatitis C. Patients will be assigned to receive Peginterferon alfa (Pegasys) 180 mcg sc once a week and Ribavirin (Copegus) 800 - 1200 mg po daily for either 24 or 48 weeks. Allocation to the treatment arms is to the discretion of the investigator (mainly according to genotype). Adverse events will be monitored throughout the study and hematologic parameters every 2 weeks and twice during the 24-week follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Experimental |
| |
| B | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus (ribavirin) | Drug | 800 - 1200 mg po daily for 24 weeks |
| |
| Copegus (ribavirin) |
| Measure | Description | Time Frame |
|---|---|---|
| safety and tolerability with regard to clinical AEs and laboratory parameters | assessed every 2 weeks throughout study and after 8 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| safety with regard to hematological parameters | assessed every 2 weeks throughout study and after 8 and 24 weeks of follow up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Afula | 18101 | Israel | ||||
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| Drug |
800 - 1200 mg po daily for 48 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc once weekly for 24 weeks |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 mcg sc once weekly for 48 weeks |
|
| Ashkelon |
| 78278 |
| Israel |
| Bat Yam | Israel |
| Beersheba | 84105 | Israel |
| Hadera | 38100 | Israel |
| Haifa | 31096 | Israel |
| Haifa | 33394 | Israel |
| Haifa | 34362 | Israel |
| Holon | 58100 | Israel |
| Jerusalem | 91120 | Israel |
| Kfar Saba | 44281 | Israel |
| Nahariya | 22100 | Israel |
| Nazareth | Israel |
| Petah Tikva | 49100 | Israel |
| Petah Tikva | Israel |
| Ramat Gan | 52621 | Israel |
| Rehovot | 76100 | Israel |
| Safed | 13110 | Israel |
| Tel Aviv | 6423906 | Israel |
| Ẕerifin | 6093000 | Israel |
| 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 |
|---|---|
| D012254 | Ribavirin |
| C100416 | peginterferon alfa-2a |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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