Interferon and Ribavirin Treatment in Patients With Hemoglobinopathies (IFNRIBAHE)
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ClinicalTrials.gov Identifier: NCT00887081 |
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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Condition or disease | Intervention/treatment | Phase |
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Hemoglobinopathies | Drug: PEG-IFN alpha2a or PEG-IFN alpha2b and Ribavirin | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 150 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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 |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | December 2013 |
Estimated Study Completion Date : | December 2013 |

Arm | Intervention/treatment |
---|---|
Experimental: Interferon and Ribavirin
Patients with hemoglobinopathy will receive Interferon and Ribavirin
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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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- 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 ]
- 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 ]

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Ages Eligible for Study: | 18 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00887081
Contact: Aurelio Maggio, M.D. | 00390916885251 | aureliomaggio@virgilio.it | |
Contact: Gaetano Restivo, M.D. | 00390916802976 | 101dalmatians@tele2.it |
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. |
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 |
Responsible Party: | Aurelio Maggio, M.D., Azienda Ospedaliera V. Cervello |
ClinicalTrials.gov Identifier: | NCT00887081 |
Other Study ID Numbers: |
AOVCervello1 |
First Posted: | April 23, 2009 Key Record Dates |
Last Update Posted: | April 23, 2009 |
Last Verified: | April 2009 |
antiviral treatment in hemoglobinopathies management of chronic viral hepatitis C infection antiviral treatment |
Hemoglobinopathies Hematologic Diseases Genetic Diseases, Inborn Ribavirin Interferon-alpha Interferon alpha-2 Interferon-alfa-1b Peginterferon alfa-2a |
Peginterferon alfa-2b Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs Antineoplastic Agents |