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| ID | Type | Description | Link |
|---|---|---|---|
| BRCGL-07-03 |
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| Name | Class |
|---|---|
| Baqiyatallah Research Center for Gastroenterology and Liver Diseases | OTHER |
| Tehran Hepatitis Center | OTHER |
| Guilan University of Medical Sciences | OTHER |
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Hemophilic patients are a known high risk groups for acquiring the hepatitis C. The surveillance data from Ministry Of Health in IR.Iran had shown that 60% of them are infected with HCV infection. We are trying the PEGASYS plus Ribavirin in Hemophilic patients with HCV.
The investigators enroll 400 patients into the study. The patients receive PEGASYS (Peginterferon alpha-2a(40 KD)) 180 microgram per week plus COPEGUS (Ribavirin) 800 microgram for Genotype 2 and 3 and 1000 milligram for weight less than 75 kg and 1200 milligram for more than 75 kg. The duration of protocol is depends on genotypes of virus. In genotype 1 and 4, for 48 week and in genotypes 2 and 3 , for 24 weeks. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA 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. We have omitted the liver biopsy in the patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Genotype 2 or 3 in Hemophilic Patients with HCV |
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| 2 | Active Comparator | Other Genotypes (except 2 or 3) in Hemophilic 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: 800 milligram per day (PO) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Early Virologic Response | After 12 weeks of Treatment | |
| End of Treatment Response | 24 weeks for : Genotype 2 & 3; 48 Weeks for other genotype | |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Professor Seyed-Moayed Alavian, Professor | Baqiyatallah Research Center for Gastroenterology and Liver Diseases | Study Chair |
| Seyyed Mohammad Miri, M.D. | Baqiyatallah Research Center for Gastroenterology and Liver Diseases | Study Director |
| 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 |
| Pegah Karimi, M.D. | Baqiyatallah Research Center for Gastroenterology and Liver Diseases | Principal Investigator |
| Bashir HajiBeigi, M.D. | Iranian Blood Transfusion Research Center |
| 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 |
|---|---|---|---|
| 12703472 | Background | Iafolla M. [Pegasys: FDA approved Pegasys (peginterferon alfa-2a) for the treatment of hepatitis C]. Sidahora. 2002;(4):8-10. No abstract available. Spanish. |
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| Tabriz Research Center for Gastroenterology and Liver Diseases |
| UNKNOWN |
| Shahid Beheshti University of Medical Sciences | OTHER |
| Iran University of Medical Sciences | OTHER |
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| 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)] |
|
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| During Treatment AND End of treatment |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006467 | Hemophilia A |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D025861 | Blood Coagulation Disorders, Inherited |
| D001778 | Blood Coagulation Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D020147 | Coagulation Protein Disorders |
| D006474 | Hemorrhagic Disorders |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| C100416 | peginterferon alfa-2a |
| D012254 | Ribavirin |
| ID | Term |
|---|---|
| D012263 | Ribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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