Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies (IFNRIBAHE)
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| ClinicalTrials.gov Identifier: NCT00887081 |
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Recruitment Status : Unknown
Verified April 2009 by Azienda Ospedaliera V. Cervello.
Recruitment status was: Recruiting
First Posted : April 23, 2009
Last Update Posted : April 23, 2009
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Sponsor:
Azienda Ospedaliera V. Cervello
Information provided by:
Azienda Ospedaliera V. Cervello
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| First Submitted Date ICMJE | April 21, 2009 | |||||||||
| First Posted Date ICMJE | April 23, 2009 | |||||||||
| Last Update Posted Date | April 23, 2009 | |||||||||
| Study Start Date ICMJE | January 2009 | |||||||||
| Estimated Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | |||||||||
| Original Primary Outcome Measures ICMJE | Same as current | |||||||||
| Change History | No Changes Posted | |||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | |||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | |||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | |||||||||
| Descriptive Information | ||||||||||
| Brief Title ICMJE | Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies | |||||||||
| Official Title ICMJE | Phase IV Study of Effectiveness of Interferon and Ribavirin Treatment in Thalassemia Major Patients With Chronic Viral Hepatitis C | |||||||||
| 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 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. | |||||||||
| 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 ICMJE | Interventional | |||||||||
| Study Phase ICMJE | Phase 4 | |||||||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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| Condition ICMJE | Hemoglobinopathies | |||||||||
| Intervention ICMJE | 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:
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| Study Arms ICMJE | Experimental: Interferon and Ribavirin
Patients with hemoglobinopathy will receive Interferon and Ribavirin
Intervention: Drug: PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin
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| Publications * | Not Provided | |||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status ICMJE | Unknown status | |||||||||
| Estimated Enrollment ICMJE |
150 | |||||||||
| Original Estimated Enrollment ICMJE | Same as current | |||||||||
| Estimated Study Completion Date ICMJE | December 2013 | |||||||||
| Estimated Primary Completion Date | December 2013 (Final data collection date for primary outcome measure) | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years to 60 Years (Adult) | |||||||||
| Accepts Healthy Volunteers ICMJE | No | |||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||||||||
| Listed Location Countries ICMJE | Italy | |||||||||
| Removed Location Countries | ||||||||||
| Administrative Information | ||||||||||
| NCT Number ICMJE | NCT00887081 | |||||||||
| Other Study ID Numbers ICMJE | AOVCervello1 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product | Not Provided | |||||||||
| IPD Sharing Statement ICMJE | Not Provided | |||||||||
| Responsible Party | Aurelio Maggio, M.D., Azienda Ospedaliera V. Cervello | |||||||||
| Study Sponsor ICMJE | Azienda Ospedaliera V. Cervello | |||||||||
| Collaborators ICMJE | Not Provided | |||||||||
| Investigators ICMJE |
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| PRS Account | Azienda Ospedaliera V. Cervello | |||||||||
| Verification Date | April 2009 | |||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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