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This study will evaluate the efficacy and safety of 4 regimens of PEGASYS plus Copegus, in patients with chronic hepatitis C (CHC) genotype 1 who have failed to respond to previous treatment with standard doses of PEGASYS plus ribavirin. Patients will be randomized to one of 4 groups, to receive a)PEGASYS 360 micrograms/week plus Copegus 1000-1200mg/day, b)PEGASYS 180 micrograms twice weekly plus Copegus 1000-1200mg/day, c)PEGASYS 360micrograms/week plus Copegus 1200-1600mg/day, or d)PEGASYS 180 micrograms twice weekly plus Copegus 1200-1600mg/day. Following 48 weeks treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Copegus | Drug | 1200-1600mg/day po |
| |
| Copegus |
| Measure | Description | Time Frame |
|---|---|---|
| Sustained viral response | Week 72 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients with >=2log drop of HCV-RNA | Week 4, 12, 24. | |
| Percentage of patients with non-detectable HCV-RNA | Week 48 | |
| Relapse rate |
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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 |
|---|---|---|---|---|---|---|
| Angers | 49033 | France | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21439960 | Derived | Chevaliez S, Hezode C, Soulier A, Costes B, Bouvier-Alias M, Rouanet S, Foucher J, Bronowicki JP, Tran A, Rosa I, Mathurin P, Alric L, Leroy V, Couzigou P, Mallat A, Charaf-Eddine M, Babany G, Pawlotsky JM. High-dose pegylated interferon-alpha and ribavirin in nonresponder hepatitis C patients and relationship with IL-28B genotype (SYREN trial). Gastroenterology. 2011 Jul;141(1):119-27. doi: 10.1053/j.gastro.2011.03.039. Epub 2011 Mar 24. |
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| Drug |
1000-1200mg/day po |
|
| peginterferon alfa-2a [Pegasys] | Drug | 360 micrograms sc weekly |
|
| peginterferon alfa-2a [Pegasys] | Drug | 180 micrograms sc twice weekly |
|
| Throughout study. |
| Bobigny |
| 93009 |
| France |
| Châteauroux | 36019 | France |
| Créteil | 94000 | France |
| Créteil | 94010 | France |
| Grenoble | 38043 | France |
| Hyères | 83407 | France |
| Lille | 59037 | France |
| Limoges | 87042 | France |
| Marseille | 13285 | France |
| Marseille | 13385 | France |
| Metz | 57038 | France |
| Montpellier | 34295 | France |
| Nice | 06202 | France |
| Paris | 75651 | France |
| Paris | 75679 | France |
| Pessac | 33604 | France |
| Poitiers | 86021 | France |
| Strasbourg | 67091 | France |
| Toulouse | 31059 | France |
| Vandœuvre-lès-Nancy | 54511 | France |
| Villejuif | 94804 | France |
| 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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