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This observational study will evaluate the predictive value of rapid virological response (RVR) and early virological response (EVR) on sustained virological response (SVR) by stage of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will be followed for 48 weeks of treatment and up to 24 weeks of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort |
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response (SVR) rate, in relation to rapid virological response (RVR) in different stages of liver fibrosis in treatment-naïve patients with chronic hepatitis C genotype 1 | approximately 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Safety: Incidence of adverse events | approximately 3 years | |
| Sustained virological response (SVR) rate, in relation to early virological response (EVR) in different stages of liver fibrosis in treatment naïve patients with chronic hepatitis C genotype 1 |
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Inclusion Criteria:
Exclusion Criteria:
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Treatment-naïve patients with chronic hepatitis C genotype 1 initiated on treatment with Pegasys and Copegus
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bydgoszcz | 85-030 | Poland | ||||
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| approximately 3 years |
| Response rates (RVR, EVR, SVR) according to host/virus/treatment-related factors in different stages of liver fibrosis (F>/=3 and </=3) | approximately 3 years |
| Bytom |
| 41-902 |
| Poland |
| Chorzów | 41-500 | Poland |
| Ciechanów | 06-400 | Poland |
| Dębica | 39-200 | Poland |
| Katowice | 40-752 | Poland |
| Koszalin | 75-581 | Poland |
| Lodz | 91-357 | Poland |
| Mielec | 39-300 | Poland |
| Puławy | 24-100 | Poland |
| Radom | 26-600 | Poland |
| Warsaw | 04-141 | Poland |
| Wałbrzych | 58-300 | Poland |
| Łańcut | 37-100 | Poland |
| 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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