Status:
COMPLETED
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Patients With Chronic Hepatitis C
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief Summary
This study evaluated the efficacy and safety of the combination of peginterferon alfa-2a plus ribavirin in treatment-naïve patients with HCV genotype 1b infection, compared with peginterferon alfa-2a ...
Detailed Description
Treatment-naïve patients were randomly assigned in a 1:1 ratio to 48 weeks of double-blind treatment with subcutaneous, once-weekly injections of 180 μg of peginterferon alfa-2a (40KD) plus either twi...
Eligibility Criteria
Inclusion
- Adult patients with quantifiable serum HCV-RNA (≥500 IU/mL))
- elevated serum alanine aminotransferase activity (≥45 IU per liter)within six months of screening
- liver biopsy findings consistent with a diagnosis of chronic hepatitis C.
Exclusion
- Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
- leukopenia (fewer than 3,000 white blood cells per cubic millimeter)
- thrombocytopenia (fewer than 90,000 platelets per cubic millimeter)
- anemia (less than 12 g hemoglobin per deciliter )
- hepatitis B co-infection
- decompensated liver disease
- organ transplant
- creatinine clearance less than 50 milliliters per minute
- poorly controlled psychiatric disease
- poorly controlled diabetes
- malignant neoplastic disease
- severe cardiac or chronic pulmonary disease
- immunologically mediated disease
- retinopathy.
Key Trial Info
Start Date :
May 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2005
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00144469
Start Date
May 1 2002
End Date
March 1 2005
Last Update
February 2 2009
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