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The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice.
Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Overall study population. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PegIntron (peginterferon alfa-2b; SCH 54031) | Drug | PegIntron administered in accordance with approved labeling Subcutaneous injection once weekly for 24 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall incidence of adverse events and adverse drug reactions. | Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study | |
| Assessment of trends of adverse drug reactions by patient factors and concomitant medications; Incidence, severity, and outcome of adverse events (AEs) between the elderly vs younger patients | Assessed from the time the informed consent is signed up until 30 days after completion or discontinuation from the study | |
| Sustained virologic response rate by HCV genotype, baseline viral load, and patient demographic characteristics | Assessed at 24 weeks post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of ALT normalization at end of treatment period and at 24 weeks post completing therapy. | End of treatment and 24 weeks after end of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic hepatitis C excluding subjects with HCV genotype 1 and high viral load, and interferon-naïve subjects with low viral load. Patients undergoing treatment with PegIntron and Rebetol in clinical practice at approximately 50 to 100 sites in Japan.
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|
| Rebetol (ribavirin; SCH 18908) | Drug | Rebetol administered orally twice daily in accordance with approved labeling. Dosing duration 24 weeks. |
|
|
| 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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