Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:49 PM
Study NCT ID:
NCT00004851
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
2000-03-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'enrollmentInfo': {'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2000-03', 'completionDateStruct': {'date': '2001-05'}, 'lastUpdateSubmitDate': '2008-03-03', 'studyFirstSubmitDate': '2000-03-02', 'studyFirstSubmitQcDate': '2002-12-09', 'lastUpdatePostDateStruct': {'date': '2008-03-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-12-10', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['HCV Antibody Library'], 'conditions': ['Hepatitis C']}, 'referencesModule': {'references': [{'pmid': '6799586', 'type': 'BACKGROUND', 'citation': 'Feinstone SM, Alter HJ, Dienes HP, Shimizu Y, Popper H, Blackmore D, Sly D, London WT, Purcell RH. Non-A, non-B hepatitis in chimpanzees and marmosets. J Infect Dis. 1981 Dec;144(6):588-98. doi: 10.1093/infdis/144.6.588.'}, {'pmid': '8383220', 'type': 'BACKGROUND', 'citation': 'Hijikata M, Shimizu YK, Kato H, Iwamoto A, Shih JW, Alter HJ, Purcell RH, Yoshikura H. Equilibrium centrifugation studies of hepatitis C virus: evidence for circulating immune complexes. J Virol. 1993 Apr;67(4):1953-8. doi: 10.1128/JVI.67.4.1953-1958.1993.'}, {'pmid': '8107212', 'type': 'BACKGROUND', 'citation': 'Shimizu YK, Hijikata M, Iwamoto A, Alter HJ, Purcell RH, Yoshikura H. Neutralizing antibodies against hepatitis C virus and the emergence of neutralization escape mutant viruses. J Virol. 1994 Mar;68(3):1494-500. doi: 10.1128/JVI.68.3.1494-1500.1994.'}]}, 'descriptionModule': {'briefSummary': 'To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.', 'detailedDescription': 'To generate a library of genes that reflect the entirety of antibody responses to hepatitis C virus (HCV) made during the 20-year course of HCV infection in a single patient (WH) whose viral quasispecies has been extensively characterized. In addition to characterizing the sequential events in antibody formation and their relationship to the changing pattern of viral quasispecies, we hope to identify neutralizing antibodies and the epitopes to which they are directed. Ultimately we seek to gain insight into the host mechanisms that suppress viral replication and to translate this to therapeutic and preventive modalities.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Persistent infection with mild hepatitis that is non-progressive.'}, 'identificationModule': {'nctId': 'NCT00004851', 'briefTitle': 'Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies', 'organization': {'class': 'NIH', 'fullName': 'National Institutes of Health Clinical Center (CC)'}, 'officialTitle': 'Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies', 'orgStudyIdInfo': {'id': '990090'}, 'secondaryIdInfos': [{'id': '99-CC-0090'}]}, 'contactsLocationsModule': {'locations': [{'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren G. Magnuson Clinical Center (CC)', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Institutes of Health Clinical Center (CC)', 'class': 'NIH'}}}}