Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies (IFNRIBAHE)

April 22, 2009 updated by: Azienda Ospedaliera V. Cervello

Phase IV Study of Effectiveness of Interferon and Ribavirin Treatment in Thalassemia Major Patients With Chronic Viral Hepatitis C

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 are HCV-RNA positive. In Italy and worldwide, genotype 1 is the most frequent. Regarding the prevalence of cirrhosis, the clinical data of different cohorts of thalassemia patients showed a rate of cirrhosis ranging from 10% to 20%. Male sex, high serum ALT values, and a positive serum test for qualitative HCV-RNA are significantly associated with severe fibrosis or cirrhosis. Cirrhosis related to hepatitis C virus infection is the major risk factor for development of hepatocellular carcinoma and is a major cause of liver failure. An Italian study that reported clinical data of 22 thalassemia patients with hepatocellular carcinoma concluded that the development of hepatocellular carcinoma is associated with the presence of cirrhosis, male gender, age over 35 years, and active HCV infection. Another prospective study reported a 2% incidence of new HCC during the follow-up of 105 adult thalassemia patients cohort. Yet before 2000, several controlled trials reported that combination therapy with alpha-interferon, given three times a week, and ribavirin, given every day, was more effective than interferon alone.Recently, three different studies reported the efficacy and the safety of combination therapy with pegylated interferon and ribavirin in thalassemic patients. Less extensive data are present actually in literature about efficacy of combination therapy with pegylated interferon and ribavirin in HCV infected patients with sickle cell disease or sickle/beta-thalassemia.

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Palermo, Italy, 90100
        • Recruiting
        • AOVCervello
        • Contact:
        • Contact:
        • Principal Investigator:
          • Disma Renda, M.D.
        • Sub-Investigator:
          • Michele Rizzo, M.D.
        • Principal Investigator:
          • Paolo Rigano, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Interferon and Ribavirin
Patients with hemoglobinopathy will receive Interferon and Ribavirin
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.
Other Names:
  • Rebetol
  • Pegasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: from 6 to 12 months
from 6 to 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: from 6 to 12 months
from 6 to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliera V. Cervello

Investigators

  • Study Chair: Aurelio Maggio, M.D., Azienda Ospedaliera V. Cervello
  • Principal Investigator: Gaetano Restivo, M.D., Azienda Ospedaliera V. Cervello
  • Study Director: Disma Renda, M.D., Azienda Ospedaliera V. Cervello

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

April 21, 2009

First Submitted That Met QC Criteria

April 22, 2009

First Posted (Estimate)

April 23, 2009

Study Record Updates

Last Update Posted (Estimate)

April 23, 2009

Last Update Submitted That Met QC Criteria

April 22, 2009

Last Verified

April 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AOVCervello1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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