Status:
COMPLETED
A Study of Peginterferon Alfa-2a in Combination With Ribavirin in Chronic Hepatitis C (CHC) Patients With Compensated Liver Cirrhosis (LC)
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Liver Cirrhosis
Chronic Hepatitis C
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
This study evaluated the clinical response of the efficacy and safety of the combination therapy of peginterferon alfa-2a and ribavirin, compared with an antiviral treatment-free group in CHC patients...
Eligibility Criteria
Inclusion
- Patients aged 20 to 75 years-old with quantifiable serum HCV-RNA (≥ 500 IU/mL), elevated serum alanine aminotransferase activity (≥ 45 IU per liter) within sixty days of screening, and proven CHC with compensated LC (Child-Pugh A) on liver biopsy.
Exclusion
- Patients with neutropenia (fewer than 1,500 neutrophils per cubic millimeter)
- Thrombocytopenia (fewer than 75,000 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 :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT00304551
Start Date
June 1 2006
End Date
June 1 2010
Last Update
June 3 2010
Active Locations (8)
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1
Chugoku
Chugoku, Japan
2
Hokkaido Region
Hokkaido, Japan
3
Kanto Region
Kanto, Japan
4
Kinki Region
Kinki, Japan