Hemoglobinopathies | Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies
Hemoglobinopathies research study
What is the primary objective of this study?
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.
Who is eligible to participate?
Inclusion Criteria: - Thalassemia Major or Sickle Cell Disease or Sickle/Beta Thalassemia patients - Regularly transfused (hemoglobin ≥ 9.5 gr/dl) or not transfused, under or not iron chelation regimen - With positivity to HCV-RNA and chronic liver disease with or without cirrhosis, naïve or non-responder or relapser after interferon mono-therapy Exclusion Criteria: - Thalassemia Major or Sickle Cell Disease or Sickle/Beta Thalassemia patients with not compensated liver failure or heart failure - Low white blood cells (neutrophils < 1.500/mmc and/or white blood cells < 3.000/mmc) - Low platelets count (< 100.000/mmc) - Significant positivity to Coombs test with clinical and serologic evidence of immune hemolytic anemia, severe endocrinopathy, detection of high titre autoantibodies, co-infection with HBV (HbsAg positive)
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Drug:PEG-IFN alpha2a or PEG-IFN alpha2b and RibavirinPEG-IFN alpha2a 180 mcg weekly or PEG-IFN alpha2b 1.5 mcg/kg of body weight weekly plus ribavirin 800-1200 mg daily according to body weight.
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
Interferon and RibavirinPatients with hemoglobinopathy will receive Interferon and Ribavirin
Start Date: January 2009
Completed Date: December 2013
Phase: Phase 4
Primary Outcome: 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.
Secondary Outcome: Early virological response (EVR) , defined as the loss of HCV RNA during the first 12 weeks of therapy; main side effects enclosing changes in blood transfusion requirement; increase in ferritin levels and variations in chelation treatment
Study sponsors, principal investigator, and references
Principal Investigator: Aurelio Maggio, M.D.
Lead Sponsor: Azienda Ospedaliera V. Cervello