Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies (IFNRIBAHE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2009 by Azienda Ospedaliera V. Cervello.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Azienda Ospedaliera V. Cervello
ClinicalTrials.gov Identifier:
NCT00887081
First received: April 21, 2009
Last updated: April 22, 2009
Last verified: April 2009
  Purpose

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.


Condition Intervention Phase
Hemoglobinopathies
Drug: PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Phase IV Study of Effectiveness of Interferon and Ribavirin Treatment in Thalassemia Major Patients With Chronic Viral Hepatitis C

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera V. Cervello:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 150
Study Start Date: January 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Pegasis
  • Rebetol

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00887081

Contacts
Contact: Aurelio Maggio, M.D. 00390916885251 aureliomaggio@virgilio.it
Contact: Gaetano Restivo, M.D. 00390916802976 101dalmatians@tele2.it

Locations
Italy
AOVCervello Recruiting
Palermo, Italy, 90100
Contact: Aurelio Maggio, M.D.    00390916885251    aureliomaggio@virgilio.it   
Contact: Gaetano Restivo, M.D.    00390916802111    101dalmiatans@tele2.it   
Principal Investigator: Disma Renda, M.D.         
Sub-Investigator: Michele Rizzo, M.D.         
Principal Investigator: Paolo Rigano, M.D.         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Aurelio Maggio, M.D., Azienda Ospedaliera V. Cervello
ClinicalTrials.gov Identifier: NCT00887081     History of Changes
Other Study ID Numbers: AOVCervello1
Study First Received: April 21, 2009
Last Updated: April 22, 2009
Health Authority: Italy: Ministry of Health

Keywords provided by Azienda Ospedaliera V. Cervello:
antiviral treatment in hemoglobinopathies
management of chronic viral hepatitis C infection
antiviral treatment

Additional relevant MeSH terms:
Hemoglobinopathies
Hepatitis C
Hepatitis C, Chronic
Hematologic Diseases
Genetic Diseases, Inborn
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Chronic
Interferon-alpha
Interferons
Ribavirin
Peginterferon alfa-2a
Peginterferon alfa-2b
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014