Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

Study Overview
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Brief Summary
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Pegylation of interferon prolongs the medication half-life which has resulted in Pegylated Interferon (PEG-IFN) as the new modality for treatment of chronic hepatitis C. We current this clinical trial to assess the efficacy and safety of domestic PEG-IFN alpha-2a (Pegaferon®) in the patients with chronic hepatitis C.

Detailed Description
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We enroll 50 patients in to the study. The patients receive Pegaferon® 180 micgr per week plus ribavirin 10-15mg/kg per day. The patients are visited every 4 weeks with biochemistry lab tests. They are checked with quantitative HCV PCR on the third month after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.

Official Title
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Effectiveness and Side Effects of Pegylated Interferon Alpha-2a (Pegaferon®) Plus Ribavirin in the Patients With Chronic Hepatitis C

Conditions
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Hepatitis C

Intervention / Treatment
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* Drug: Pegylated Interferon alpha 2a + Ribavirin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV RNA: Positive Biopsy approved in genotype 1 Age older than 18 yrs Exclusion Criteria: ongoing pregnancy or breast feeding Hx of hemochromatosis Hx of metabolic liver dis. Hx of HCC Hx of autoimmune hepatitis Hx of alcoholic liver dis. Hx of bleeding from esophageal varices ongoing systemic anti-viral or anti-neoplasmic treatment Hx of treatment with an anti-depressant medication at therapeutic doses for at least 3 months at any pervious time Hx of treatment with an tranquilizer at therapeutic doses for psychosis for at least 3 months at any pervious time Hx of hospitalization for psychiatric dis. Hx of suicidal attempt Hx of IBD Hx of SLE Hx of scleroderma Hx of rheumatoid arthritis Hx of ITP Hx of autoimmune hemolytic anemia Hx of severe psoriasis Hx of chronic pulmonary dis. associated with functional limitation Hx of MI or unstable angina Hx of arrhythmia requiring ongoing treatment Hx of functional class III or IV Hx of severe seizure dis. or current anti-convulsant use Hx of organ transplantation with existing functional graft Hx of severe retinopathy Hx of Thalassemia Hx of spherocytosis Hx of cerebrovascular dis.

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pegylated Interferon alpha 2a + Ribavirin|Pegaferon: Ampule, 180 microgram per week Ribaverin: Tablet, 10-15 mg/kg per day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End of treatment response rate (HCV RNA:Neg) |  | End of treatment course | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustain response rate (HCV RNA:Neg) 6 month after end of treatment |  | 6 month after end of treatment |