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Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies

NCT00887081 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2009-04-23

No results posted yet for this study

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.

Conditions

  • Hemoglobinopathies

Interventions

DRUG

PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin

PEG-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.

Sponsors & Collaborators

  • Azienda Ospedaliera V. Cervello

    lead OTHER

Principal Investigators

  • Aurelio Maggio, M.D. · Azienda Ospedaliera V. Cervello

  • Gaetano Restivo, M.D. · Azienda Ospedaliera V. Cervello

  • Disma Renda, M.D. · Azienda Ospedaliera V. Cervello

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-01-31
Primary Completion
2013-12-31
Completion
2013-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00887081 on ClinicalTrials.gov