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This is an observational study of patients undergoing treatment with PegIntron and Rebetol for chronic hepatitis C in clinical practice in Belgium. Treatment will not be administered as part of the study. Safety parameters will be assessed retrospectively. Efficacy parameters, such as relapse rates and sustained virologic response rates, will be assessed prospectively. The objective of the study is to examine any associations between safety, virologic, histologic, demographic parameters and patient outcome (relapse rates and sustained virologic response rates).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031) | Biological | PegIntron administered at 1.5 μg/kg body weight/week subcutaneously for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) |
| Measure | Description | Time Frame |
|---|---|---|
| Safety parameters: common adverse events [AEs], drug-to-drug interaction AEs, and dose modifications | Assessed retrospectively in patients treated for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) and reaching End-of-Treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse rates and Sustained Virologic Response (SVR) rates and their association with demographic, virologic, histological, and safety parameters | Assessed prospectively at End-of-Treatment (EOT) and 24 weeks post-treatment | |
| Predictors of response at End-of-Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic hepatitis C treated with PegIntron and Rebetol in clinical practice in Belgium.
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20458844 | Result | Van Vlierberghe H, Adler M, Bastens B, Colle I, Delwaide J, Henrion J, Horsmans Y, Michielsen P, Golstein P, Mulkay JP, Van Steenbergen W, Yap P, Nevens F, Denys AM, Brasseur JP. Effectiveness and tolerability of pegylated interferon alfa-2b in combination with ribavirin for treatment of chronic hepatitis C: the PegIntrust study. Acta Gastroenterol Belg. 2010 Jan-Mar;73(1):5-11. |
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|
| Rebetol (ribavirin; SCH 18908) | Drug | Rebetol administered based on body weight 800-1200 mg/day (<65 kg : 800 mg, 65 - 85 kg : 1000 mg, >85 kg : 1200 mg) orally for up to 24 wks (Genotype [G] 2,3/low viral load G 1) or 48 weeks for (G 1,4,5) |
|
|
| Assessed at the End-of-Treatment |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| 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 |
| 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 |
|---|---|
| C417083 | peginterferon alfa-2b |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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