Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Baqiyatallah Research Center for Gastroenterology and Liver Diseases | OTHER |
| Tehran Hepatitis Center | OTHER |
| Guilan University of Medical Sciences | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Thalassemic Patients with HCV |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) | Drug | PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: [=<75 kg: 1000 mg; >75 kg: 1200 mg per day (PO)] |
| Measure | Description | Time Frame |
|---|---|---|
| Early Virologic Response | After 12 weeks of Treatment | |
| End of Treatment Response | 48 Weeks | |
| Sustained Virologic Response | 24 weeks after Treatment | |
| Rapid Virologic Response | One month after Treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Tolerability of drugs for whole therapy period | During Treatment | |
| Biochemical response (ALT) | End of Treatment AND 24 weeks after Treatment | |
| Laboratory Parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Seyed-Moayed Alavian, Professor | Baqiyatallah Research Center for Gastroenterology and Liver Disea | Study Chair |
| Seyyed Mohammad Miri, M.D. | Baqiyatallah Research Center for Gastroenterology and Liver Disea | Study Director |
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Baqiyatallah Research Center for Gastroenterology and Liver Diseases | Tehran | Tehran Province | 14155-3651 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18556414 | Background | Harmatz P, Jonas MM, Kwiatkowski JL, Wright EC, Fischer R, Vichinsky E, Giardina PJ, Neufeld EJ, Porter J, Olivieri N; Thalassemia Clinical Research Network. Safety and efficacy of pegylated interferon alpha-2a and ribavirin for the treatment of hepatitis C in patients with thalassemia. Haematologica. 2008 Aug;93(8):1247-51. doi: 10.3324/haematol.12352. Epub 2008 Jun 12. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D013789 | Thalassemia |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
Not provided
Not provided
| Tabriz Research Center for Gastroenterology and Liver Diseases |
| UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| During Treatment AND End of treatment |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |