Status:
COMPLETED
Safety and Efficacy of PegIntron Plus Rebetol in Patients With Chronic Hepatitis C in Japan, Excluding (1) Subjects With HCV Genotype 1 and High Viral Load, and (2) Interferon-naïve Subjects With Low Viral Load (Study P04841)(COMPLETED)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Hepatitis C
Eligibility:
All Genders
Brief Summary
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 w...
Eligibility Criteria
Inclusion
- Patients diagnosed with chronic hepatitis C
- Among interferon-naïve patients, only patients with high viral load and HCV genotype other than 1
- Among prior nonresponders or relapsers to interferon monotherapy, (1) patients with high viral load and HCV genotype other than 1; and (2) patients with low viral load of all genotypes (including genotype 1)
Exclusion
- Patients infected with HCV genotype 1 with high viral load, regardless of whether treatment-naïve or previous nonresponders/relapsers
- Interferon-naïve patients with low viral load
- Patients with a history of hypersensitivity to test drugs or other interferon preparations
- 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
Key Trial Info
Start Date :
February 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
505 Patients enrolled
Trial Details
Trial ID
NCT00724230
Start Date
February 1 2006
End Date
December 1 2008
Last Update
February 3 2015
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