Trial of Pegasys® in Patients With Chronic Hepatitis C
- Registration Number
- NCT00245414
- Lead Sponsor
- Chugai Pharmaceutical
- 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 for those infected with genotype 1b of hepatitis C virus (HCV) and a high viral load (≥ 100 KIU/mL).
In addition, this study will explore the efficacy and safety of Pegasys® 180μg for s.c. injection given at 2 different periods between 24 and 48 weeks in IFN-untreated chronic hepatitis C patients.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 108
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 Pegasys® Interferon (IFN)-Treated 2 Pegasys® Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1 3 Pegasys® Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1 4 Pegasys® Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1
- Primary Outcome Measures
Name Time Method Sustained viral response as undetectable level of HCV-RNA week 24 from the end of treatment
- Secondary Outcome Measures
Name Time Method Biochemical response as normal level of ALT week 24 from the end of treatment Viral response as undetectable level of HCV-RNA at the end of treatment
Trial Locations
- Locations (6)
Hokkaido Region
🇯🇵Sapporo, Japan
Chugoku Region
🇯🇵Okayama, Japan
Kinki Region
🇯🇵Osaka, Japan
Kyusyu Region
🇯🇵Fukuoka, Japan
Kanto Region
🇯🇵Tokyo, Japan
Tokai Region
🇯🇵Yamanashi, Japan