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Phase IV Study of Effectiveness of Interferon and Ribavirin Treatment in Thalassemia Major Patients With Chronic Viral Hepatitis C (IFNRIBAHE)
Worldwide, several studies report that 4.4% to 85.4% of thalassemia patients were positive for anti hepatitis C antibodies. Recently, three different studies reported the efficacy and the safety of combination therapy with pegylated interferon and ribavirin in thalassemic patients. This study is carried ahead to assess the impact of combination therapy with pegylated-interferon and ribavirin in a large cohort of italian patients with beta thalassemia major - transfused and not transfused, sickle cell disease and sickle/beta-thalassemia.
Details
| Lead sponsor | Azienda Ospedaliera V. Cervello |
|---|---|
| Phase | Phase 4 |
| Status | UNKNOWN |
| Enrolment | 150 |
| Start date | 2009-01 |
| Completion | 2013-12 |
Conditions
- Hemoglobinopathies
Interventions
- PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin
Primary outcomes
- A sustained virological response (SVR), defined as absence of HCV RNA in serum by a highly sensitive test at the end of treatment and 6 months late. — from 6 to 12 months
Countries
Italy