Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection

Study Overview
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Brief Summary
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Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.

Detailed Description
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Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months 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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A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection

Conditions
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Hepatitis C, Thalassemia

Intervention / Treatment
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* Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: HCV RNA positive Age older than 12 years Exclusion Criteria: Ongoing pregnancy or breast feeding History (Hx) of Hepatocellular Carcinoma (HCC) Hx of alcoholic liver disease Hx of bleeding from esophageal varices Hx of hemochromatosis Hx of autoimmune hepatitis Hx of Suicidal attempt Hx of cerebrovascular dis Hx of severe retinopathy Hx of severe psoriasis Hx of scleroderma Hx of metabolic liver disease Hx of Systemic Lupus Erythematosus (SLE)

Ages Eligible for Study
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Minimum Age: 12 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>Thalassemic Patients with HCV | Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)<br>* PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]<br>* Other names: Peginterferon Alfa-2a (40KD) plus COPEGUS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Virologic Response |  | After 12 weeks of Treatment | 
| End of Treatment Response |  | 48 Weeks | 
| Sustained Virologic Response |  | 24 weeks after Treatment | 
| Rapid Virologic Response |  | One month after Treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of drugs for whole therapy period |  | During Treatment | 
| Biochemical response (ALT) |  | End of Treatment AND 24 weeks after Treatment | 
| Laboratory Parameters |  | During Treatment AND End of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hepatitis C, Thalassemia, Pegasys, Ribavirin