Status:
COMPLETED
Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection
Lead Sponsor:
Baqiyatallah Medical Sciences University
Collaborating Sponsors:
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran Hepatitis Center
Conditions:
Hepatitis C
Thalassemia
Eligibility:
All Genders
12+ years
Phase:
PHASE4
Brief Summary
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 h...
Detailed Description
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 be...
Eligibility Criteria
Inclusion
- HCV RNA positive
- Age older than 12 years
Exclusion
- 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)
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT00707850
Start Date
May 1 2007
End Date
September 1 2009
Last Update
August 31 2010
Active Locations (1)
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1
Baqiyatallah Research Center for Gastroenterology and Liver Diseases
Tehran, Tehran Province, Iran, 14155-3651