Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-04-12 @ 1:47 PM
Study NCT ID:
NCT00707850
Status:
COMPLETED
Last Update Posted:
2010-08-31
First Post:
2008-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D013789', 'term': 'Thalassemia'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000745', 'term': 'Anemia, Hemolytic, Congenital'}, {'id': 'D000743', 'term': 'Anemia, Hemolytic'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006453', 'term': 'Hemoglobinopathies'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C100416', 'term': 'peginterferon alfa-2a'}, {'id': 'D012254', 'term': 'Ribavirin'}], 'ancestors': [{'id': 'D012263', 'term': 'Ribonucleosides'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'completionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-08-30', 'studyFirstSubmitDate': '2008-06-26', 'studyFirstSubmitQcDate': '2008-06-30', 'lastUpdatePostDateStruct': {'date': '2010-08-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Early Virologic Response', 'timeFrame': 'After 12 weeks of Treatment'}, {'measure': 'End of Treatment Response', 'timeFrame': '48 Weeks'}, {'measure': 'Sustained Virologic Response', 'timeFrame': '24 weeks after Treatment'}, {'measure': 'Rapid Virologic Response', 'timeFrame': 'One month after Treatment'}], 'secondaryOutcomes': [{'measure': 'Tolerability of drugs for whole therapy period', 'timeFrame': 'During Treatment'}, {'measure': 'Biochemical response (ALT)', 'timeFrame': 'End of Treatment AND 24 weeks after Treatment'}, {'measure': 'Laboratory Parameters', 'timeFrame': 'During Treatment AND End of treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Hepatitis C', 'Thalassemia', 'Pegasys', 'Ribavirin'], 'conditions': ['Hepatitis C', 'Thalassemia']}, 'referencesModule': {'references': [{'pmid': '18556414', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HCV RNA positive\n* Age older than 12 years\n\nExclusion Criteria:\n\n* Ongoing pregnancy or breast feeding\n* History (Hx) of Hepatocellular Carcinoma (HCC)\n* Hx of alcoholic liver disease\n* Hx of bleeding from esophageal varices\n* Hx of hemochromatosis\n* Hx of autoimmune hepatitis\n* Hx of Suicidal attempt\n* Hx of cerebrovascular dis\n* Hx of severe retinopathy\n* Hx of severe psoriasis\n* Hx of scleroderma\n* Hx of metabolic liver disease\n* Hx of Systemic Lupus Erythematosus (SLE)'}, 'identificationModule': {'nctId': 'NCT00707850', 'briefTitle': 'Pegasys® Plus Ribavirin in Thalassemic Patients With Hepatitis C Virus Infection', 'organization': {'class': 'OTHER', 'fullName': 'Baqiyatallah Medical Sciences University'}, 'officialTitle': 'A Study on PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin) in Iranian Thalassemic Patients With Chronic Hepatitis C Infection', 'orgStudyIdInfo': {'id': 'BRCGL-08-06'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Thalassemic Patients with HCV', 'interventionNames': ['Drug: PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)']}], 'interventions': [{'name': 'PEGASYS® (Peginterferon Alfa-2a (40KD)) Plus COPEGUS® (Ribavirin)', 'type': 'DRUG', 'otherNames': ['Peginterferon Alfa-2a (40KD) plus COPEGUS'], 'description': 'PEGASYS: 180 microgram per week (Injection) Plus Ribavirin: \\[=\\<75 kg: 1000 mg; \\>75 kg: 1200 mg per day (PO)\\]', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14155-3651', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Baqiyatallah Research Center for Gastroenterology and Liver Diseases', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Seyed-Moayed Alavian, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Baqiyatallah Research Center for Gastroenterology and Liver Disea'}, {'name': 'Seyyed Mohammad Miri, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Baqiyatallah Research Center for Gastroenterology and Liver Disea'}, {'name': 'Pegah Karimi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baqiyatallah Research Center for Gastroenterology and Liver Diseases'}, {'name': 'Maryam Keshvari, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Iranian blood Transfusion Research Center'}, {'name': 'Bita Behnava, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baqiyatallah Research Center for Gastroenterology and Liver Diseases'}, {'name': 'Mohammad Hossein Somi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Center for Gastroenterology and Hepatology, Tabriz University of Medical Sciences, Tabriz'}, {'name': 'Fariborz Mansour-Ghanaei, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gastroenterology and Liver Diseases, Gastrointestinal and Liver Diseases Research Center (GLDRC), Guilan University of Medical Sciences, Rasht, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Baqiyatallah Medical Sciences University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baqiyatallah Research Center for Gastroenterology and Liver Diseases', 'class': 'OTHER'}, {'name': 'Tehran Hepatitis Center', 'class': 'OTHER'}, {'name': 'Guilan University of Medical Sciences', 'class': 'OTHER'}, {'name': 'Tabriz Research Center for Gastroenterology and Liver Diseases', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Professor Seyed-Moayed Alavian', 'oldOrganization': 'Baqiyatallah Research Center for Gastroenterology and Liver Diseases'}}}}