drugset / Trial / NCT00887081

Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies

NCT00887081 ↗

Phase 4 Unknown 150 enrolled Azienda Ospedaliera V. Cervello
Non-randomizedSingle-groupOpen-labelHealth-services research

Summary

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.

Timeline

Start
2009-01
Primary completion
2013-12
Completion
2013-12

Drugs

EvaluationDrugModalityDoseRoute
Subject PEG-IFN alpha2b Protein / enzyme biologic 1.5 ug/kg —
Subject PegIFN-alpha-2a Protein / enzyme biologic 180 ug —
Subject Ribavirin Small molecule 800 mg —
Subject Ribavirin Small molecule 1200 mg —

Indications