Ignite Creation Date:
2025-12-25 @ 3:24 AM
Ignite Modification Date:
2025-12-26 @ 2:03 AM
Study NCT ID:
NCT00341705
Status:
COMPLETED
Last Update Posted:
2019-12-17
First Post:
2006-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Second Multicenter Hemophilia Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048550', 'term': 'Hepatic Insufficiency'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D000163', 'term': 'Acquired Immunodeficiency Syndrome'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006467', 'term': 'Hemophilia A'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D015658', 'term': 'HIV Infections'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D012897', 'term': 'Slow Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2565}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-04-27'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04-02', 'completionDateStruct': {'date': '2013-04-02'}, 'lastUpdateSubmitDate': '2019-12-14', 'studyFirstSubmitDate': '2006-06-19', 'studyFirstSubmitQcDate': '2006-06-19', 'lastUpdatePostDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-06-21', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['AIDS', 'Cancer', 'Hepatitis C Virus', 'HIV', 'Natural History', 'Hemophilia', 'Hepatitis C'], 'conditions': ['Liver Decompensation', 'Hepatocellular Carcinoma', 'Non-Hodgkin Lymphoma']}, 'referencesModule': {'references': [{'pmid': '10595759', 'type': 'BACKGROUND', 'citation': 'Mannucci PM, Tuddenbam EG. The hemophilias: progress and problems. Semin Hematol. 1999 Oct;36(4 Suppl 7):104-17.'}, {'pmid': '8106967', 'type': 'BACKGROUND', 'citation': 'Kroner BL, Rosenberg PS, Aledort LM, Alvord WG, Goedert JJ. HIV-1 infection incidence among persons with hemophilia in the United States and western Europe, 1978-1990. Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1994 Mar;7(3):279-86.'}, {'pmid': '8098752', 'type': 'BACKGROUND', 'citation': 'Eyster ME, Diamondstone LS, Lien JM, Ehmann WC, Quan S, Goedert JJ. Natural history of hepatitis C virus infection in multitransfused hemophiliacs: effect of coinfection with human immunodeficiency virus. The Multicenter Hemophilia Cohort Study. J Acquir Immune Defic Syndr (1988). 1993 Jun;6(6):602-10.'}]}, 'descriptionModule': {'briefSummary': 'The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions. Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another. Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections. Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.', 'detailedDescription': 'The Second Multicenter Hemophilia Cohort Study (MHCS-II) will evaluate and prospectively follow approximately 4500 persons with hemophilia who were exposed to hepatitis C virus (HCV). The vast majority will have been infected with HCV, and approximately 1/3 will have been infected with human immunodeficiency virus (HIV). Primary objectives are to quantify the rates of liver decompensation, hepatocellular carcinoma, and non-Hodgkin lymphoma and to evaluate candidate clinical, genetic, virologic, serologic and immunologic markers that are likely to be on the causal pathway for these conditions. Candidate clinical and laboratory markers will be examined longitudinally to define changes over time and their relationships to one another. Collaborative studies will focus on genome scanning and evaluation of candidate genetic loci for susceptibility or resistance to HCV and HIV infections or to the diseases that result from these infections. Additional studies will identify response and complication rates of various anti-HCV and anti-HIV regimens in the setting of comprehensive clinical care of persons with hemophilia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "* INCLUSION CRITERIA:\n\nMust be registered patient with an inherited coagulation disorder at a participating MHCS-II center. Disorders include hemophilia A or B (congenital factor VIII or IX deficiency), deficiencies in other factors such as V or XI, and vonWillebrand's disease. (Unless noted otherwise, all of the disorders will collectively be referred to as hemophilia .) All such hemophilia and vonWillebrand s disease patients are to be recruited as study participants.\n\nSince January 1, 1993, must have had at least one positive result on a licensed assay for HCV antibodies, HIV antibodies, or HIV RNA.\n\nMust be at least 13 years of age at enrollment.\n\nMust provide signed informed consent or, for minors, signed assent plus signed informed consent from the parent or guardian.\n\nEXCLUSION CRITERIA:\n\nIs not a patient with an inherited coagulation disorder.\n\nDoes not have a positive test for HCV antibodies, HIV antibodies, or HIV RNA on a licensed assay performed since January 1, 1993.\n\nIs less than 13 years of age.\n\nLacks informed consent/assent."}, 'identificationModule': {'nctId': 'NCT00341705', 'briefTitle': 'The Second Multicenter Hemophilia Cohort Study', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'The Second Multicenter Hemophilia Cohort Study', 'orgStudyIdInfo': {'id': '999901170'}, 'secondaryIdInfos': [{'id': '01-C-N170'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '92613', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital of Orange County", 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80220-3706', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'Christiana Hospital', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '20007-2197', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Georgetown University', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Childrens National Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '30322-1102', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60614-3394', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Childrens Memorial Hospital, Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '70112-2699', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State University Hutzel Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55415', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '39216', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '63104', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11042', 'city': 'Lake Success', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore Long Island Jewish Health System', 'geoPoint': {'lat': 40.77066, 'lon': -73.71763}}, {'zip': '10021-4872', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10029-0574', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mt. Sinai Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599-7030', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45229-3039', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Childrens Hospital, Cinncinati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '45267', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University of Cincinnati', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45435', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Wright State University', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Milton Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104-6056', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107-6541', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29202', 'city': 'Columbia', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Palmentto Health Alliance', 'geoPoint': {'lat': 34.00071, 'lon': -81.03481}}, {'zip': '38103', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'University of Tennessee', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas, San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84112', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Childrens Hospital of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital Brigadeiro', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'city': 'New Brunswick', 'country': 'Canada', 'facility': 'South East Health Care Corporation'}, {'city': 'Lyon', 'country': 'France', 'facility': 'Hospices Civils de Lyon', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'city': 'Bonn', 'country': 'Germany', 'facility': 'University of Bonn', 'geoPoint': {'lat': 50.73438, 'lon': 7.09549}}, {'city': 'Athens', 'country': 'Greece', 'facility': 'Laikon General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Florence', 'country': 'Italy', 'facility': 'University of Florence', 'geoPoint': {'lat': 43.77925, 'lon': 11.24626}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'University de Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska Institute St. Gorans Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'James J Goedert, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Institute (NCI)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'collaborators': [{'name': 'Multicenter Hemophilia Cohort Study', 'class': 'UNKNOWN'}]}}}