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

Study Overview
=================
Brief Summary
-----------------
Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.

Detailed Description
-----------------
The investigators enroll 400 patients into the study. The patients receive PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 800 microgram for Genotype 2 and 3 and 1000 milligram for weight less than 75 kg and 1200 milligram for more than 75 kg. The duration of protocol is depends on genotypes of virus. In genotype 1 and 4, for 48 week and in genotypes 2 and 3 , for 24 weeks. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA 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. We have omitted the liver biopsy in the patients.

Official Title
-----------------
A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection

Conditions
-----------------
Hepatitis C, Hemophilia

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HCV RNA positive Age older than 12 years Exclusion Criteria: Ongoing pregnancy or breast feeding Hx of 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 SLE

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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 |
| --- | --- |
| Active Comparator: 1<br>Genotype 2 or 3 in Hemophilic Patients with HCV | Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)<br>* PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: 800 milligram per day (PO)<br>* Other names: Peginterferon Alfa-2a (40KD) Plus COPEGUS;|
| Active Comparator: 2<br>Other Genotypes (except 2 or 3) in Hemophilic 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?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Virologic Response |  | After 12 weeks of Treatment | 
| End of Treatment Response |  | 24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype | 
| 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
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, Hemophilia, Pegasys, Ribavirin