Brief Title
Pegasys® Plus Ribavirin in Hemophilic Patients With Hepatitis C Virus Infection
Official Title
A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Hemophilic Patients With Chronic Hepatitis C Infection
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.
Study Phase
Phase 4
Study Type
Interventional
Primary Outcome
Early Virologic Response
Secondary Outcome
Tolerability of drugs for whole therapy period
Condition
Hepatitis C
Intervention
PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
Study Arms / Comparison Groups
1
Description: Genotype 2 or 3 in Hemophilic Patients with HCV
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
400
Start Date
March 2007
Completion Date
September 2009
Primary Completion Date
September 2009
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
Gender
All
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Professor Seyed-Moayed Alavian, Professor, ,
Location Countries
Iran, Islamic Republic of
Location Countries
Iran, Islamic Republic of
Administrative Informations
NCT ID
NCT00707772
Organization ID
BRCGL-07-03
Secondary IDs
BRCGL-07-03
Study Sponsor
Baqiyatallah Medical Sciences University
Collaborators
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Study Sponsor
Professor Seyed-Moayed Alavian, Professor, Study Chair, Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Verification Date
September 2009