Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)
NCT ID: NCT00724295
Last Updated: 2015-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1077 participants
OBSERVATIONAL
2005-04-30
2008-12-31
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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PROSPECTIVE
Study Groups
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Arm 1
Overall study population
peginterferon alfa-2b
PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.
ribavirin
Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.
Interventions
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peginterferon alfa-2b
PegIntron powder (reconstituted) administered in accordance with approved labeling; Subcutaneous injection of 1.5 ug/kg once weekly for 48 weeks.
ribavirin
Rebetol capsule administered orally twice daily in accordance with approved labeling (weight based dosing). Dosing duration 48 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients are serogroup 1(genotype I (1a) or II (1b)).
* The HCV-RNA level in the blood is more than 10\^5 IU/mL by RT-PCR method, or 1Meq./mL by b-DNA method
Exclusion Criteria
* Patients with a history of hypersensitivity to biological products, such as vaccines
* Patients being treated with Shosaikoto
* Patients with autoimmune hepatitis
* Pregnant women, women who may be pregnant, and nursing mothers
* Patients with a history of hypersensitivity to any component of this drug or other nucleoside analogs (aciclovir, ganciclovir, vidarabine, etc.)
* Patients with difficult-to-control cardiac disease (eg, myocardial infarction, cardiac failure, arrhythmia)
* Patients with hemoglobinopathies (eg, thalassemia, sickle-cell anemia)
* Patients with chronic renal failure or renal function disorder with creatinine clearance of \<=50 mL/min
* Patients with or a history of severe psychiatric condition such as severe depression, suicidal ideation or suicide attempt
* Patients with serious hepatic dysfunction
* Patients with autoimmune hepatitis
ALL
No
Sponsors
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Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Other Identifiers
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P04505
Identifier Type: -
Identifier Source: org_study_id
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