Status:
UNKNOWN
Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies
Lead Sponsor:
Azienda Ospedaliera V. Cervello
Conditions:
Hemoglobinopathies
Eligibility:
All Genders
18-60 years
Phase:
PHASE4
Brief 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 co...
Detailed Description
Infection is more common in patients who received a high number of blood transfusions before 1990. The prevalence of HCV infection is higher in Italy, where more than 70% of thalassemia major patients...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2013
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00887081
Start Date
January 1 2009
End Date
December 1 2013
Last Update
April 23 2009
Active Locations (1)
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1
AOVCervello
Palermo, Italy, 90100