Status:
COMPLETED
Trial of Pegasys® in Patients With Chronic Hepatitis C
Lead Sponsor:
Chugai Pharmaceutical
Conditions:
Chronic Hepatitis C
Eligibility:
All Genders
20+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to investigate the efficacy and safety of Pegasys® 180μg for subcutaneous (s.c.) injection in interferon (IFN)-treated or IFN-untreated chronic hepatitis C patients except...
Eligibility Criteria
Inclusion
- Quantitative serum HCV-RNA is positive except for high viral load of genotype 1b (≥ 100 KIU/mL)
- Observation of serum ALT elevation above upper limit of normal
- Chronic hepatitis is evaluated as the negative result (\< 0) calculated by the method of "formula for discrimination between chronic hepatitis and liver cirrhosis."
Exclusion
- Observation of white blood cells ≦ 3000/mm3; neutrophils ≦ 1500/mm3; platelets ≦ 90,000/mm3; or hemoglobin ≦ 10 g/dL.
- Observation of the following situations and disease: severe renal disease, hepatitis B co-infection, de-compensated liver disease, liver cirrhosis, hepatocellular carcinoma, poorly controlled psychiatric disease, seizure disorders, immunologically mediated disease, severe cardiac disease, poorly uncontrolled hypertension, poorly controlled diabetes, chronic pulmonary disease, retinopathy, malignant tumor, and organ transplant
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
108 Patients enrolled
Trial Details
Trial ID
NCT00245414
Start Date
October 1 2005
End Date
July 1 2010
Last Update
November 17 2010
Active Locations (6)
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1
Kyusyu Region
Fukuoka, Japan
2
Chugoku Region
Okayama, Japan
3
Kinki Region
Osaka, Japan
4
Hokkaido Region
Sapporo, Japan