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Sponsors and Collaborators: |
Baqiyatallah Medical Sciences University Baqiyatallah Research Center for Gastroenterology and Liver Diseases Tehran Hepatitis Center Guilan Research Center for Gastroenterology and Liver Diseases Tabriz Research Center for Gastroenterology and Liver Diseases |
Information provided by: | Baqiyatallah Medical Sciences University |
ClinicalTrials.gov Identifier: | NCT00707850 |
Antiviral treatment of HCV in thalassemia has raised concerns of ribavirin-induced hemolysis and increased iron loading. Blood Transfusion in Thalassemic patients are a known high risk for acquiring hepatitis C. The investigators are trying the PEGASYS (Peginterferon alpha-2a(40 KD)) plus Ribavirin in Thalassemic patients with HCV.
Condition | Intervention | Phase |
Hepatitis C Thalassemia |
Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) |
Phase IV |
Genetics Home Reference related topics: | beta thalassemia |
MedlinePlus related topics: | Hepatitis Hepatitis C Liver Diseases Thalassemia |
Drug Information available for: | Ribavirin Peginterferon Alfa-2a |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection |
Estimated Enrollment: | 300 |
Study Start Date: | May 2007 |
Estimated Study Completion Date: | June 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
Thalassemic Patients with HCV
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Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)
PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)]
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Patients with Thalassemia receive chronic blood transfusions and have an increased prevalence of chronic Hepatitis C virus (HCV) infection, particularly if transfused before HCV serological testing became available. The investigators enrolled 300 patients into the study. The patients received PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 1000 milligram for weight less than or equal 75 kg and 1200 milligram for more than 75 kg for 48 weeks. Follow up period is 6 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the third months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the six month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
Ages Eligible for Study: | 12 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Seyed-Moayed Alavian, Professor | +98 218126 4070 | alavian@thc.ir |
Contact: Seyyed Mohammad Miri, M.D. | +98 218126 4070 | manager@hepmon.ir |
Iran, Islamic Republic of | |||||
Baqiyatallah Research Center for Gastroenterology and Liver Diseases | Recruiting | ||||
Tehran, Iran, Islamic Republic of, 14155-3651 | |||||
Contact: Seyyed Mohammad Miri, M.D. +98 9123062496 manager@hepmon.ir | |||||
Principal Investigator: Seyyed Mohammad Miri, M.D. |
Baqiyatallah Medical Sciences University |
Baqiyatallah Research Center for Gastroenterology and Liver Diseases |
Tehran Hepatitis Center |
Guilan Research Center for Gastroenterology and Liver Diseases |
Tabriz Research Center for Gastroenterology and Liver Diseases |
Study Chair: | Seyed-Moayed Alavian, Professor | Baqiyatallah Research Center for Gastroenterology and Liver Disea |
Study Director: | Seyyed Mohammad Miri, M.D. | Baqiyatallah Research Center for Gastroenterology and Liver Disea |
Principal Investigator: | Pegah Karimi, M.D. | Baqiyatallah Research Center for Gastroenterology and Liver Diseases |
Principal Investigator: | Maryam Keshvari, M.D. | Iranian blood Transfusion Research Center |
Principal Investigator: | Bita Behnava, M.D. | Baqiyatallah Research Center for Gastroenterology and Liver Diseases |
Principal Investigator: | Mohammad Hossein Somi, M.D. | Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz |
Principal Investigator: | Fariborz Mansour-Ghanaei, M.D. | Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran |
Baqiyatallah Research Center for Gastroenterology and Liver Diseases 
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Responsible Party: | Baqiyatallah Research Center for Gastroenterology and Liver Diseases ( Professor Seyed-Moayed Alavian ) |
Study ID Numbers: | BRCGL-08-06 |
First Received: | June 26, 2008 |
Last Updated: | June 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00707850 |
Health Authority: | Iran: Ministry of Health |
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