Status:
COMPLETED
Safety and Efficacy of PegIntron and Rebetol Combination Therapy in Patients With Chronic Hepatitis C in Japan (Study P04505)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Hepatitis C, Chronic
Hepatitis C
Eligibility:
All Genders
Brief Summary
This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evalua...
Eligibility Criteria
Inclusion
- Patients with chronic hepatitis C.
- 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
- 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 :
April 1 2005
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
1077 Patients enrolled
Trial Details
Trial ID
NCT00724295
Start Date
April 1 2005
End Date
December 1 2008
Last Update
February 4 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.