Trial of Pegasys® in Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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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.

Official Title
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Post-marketing Clinical Trial of Pegasys® 180μg for Subcutaneous Injection in Patients With Chronic Hepatitis C. General Clinical Study in Interferon (IFN)-Treated and IFN-untreated Chronic Hepatitis C Patients, Except for Those Infected With High Viral Load of Genotype 1b

Conditions
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Chronic Hepatitis C

Intervention / Treatment
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* Drug: Pegasys®
* Drug: Pegasys®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Interferon (IFN)-Treated | Drug: Pegasys®<br>* 180μg for s.c./week for 48 weeks<br>|
| Experimental: 2<br>Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is positive at week 1 | Drug: Pegasys®<br>* 180μg for s.c./week for 48 weeks<br>|
| Experimental: 3<br>Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1 | Drug: Pegasys®<br>* 180μg for s.c./week for 48 weeks<br>|
| Experimental: 4<br>Interferon (IFN)-Untreated and Quantitative serum HCV-RNA is negative at week 1 | Drug: Pegasys®<br>* 180μg for s.c./week for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained viral response as undetectable level of HCV-RNA |  | week 24 from the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |