Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02011932
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2013-12-17
First Post:
2013-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Observational Study of Disease Progression in Chronic Hepatitis C
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019698', 'term': 'Hepatitis C, Chronic'}, {'id': 'D018450', 'term': 'Disease Progression'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}], 'ancestors': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005355', 'term': 'Fibrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'whole blood, serum, plasma,liver biopsies specimens,'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2010-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2030-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-12-13', 'studyFirstSubmitDate': '2013-12-06', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2013-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fibrosis progression rate', 'timeFrame': '20 years'}, {'measure': 'The incidence of cirrhosis', 'timeFrame': '20 years'}, {'measure': 'Risk factors for the occurrence of cirrhosis', 'timeFrame': '20 years'}], 'secondaryOutcomes': [{'measure': 'The incidence of hepatocellular carcinoma', 'timeFrame': '20 years'}, {'measure': 'Number of participants with chronic hepatitis C-related complications', 'timeFrame': '20 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hepatitis C, Chronic', 'Disease Progression', 'Liver Cirrhosis']}, 'referencesModule': {'references': [{'pmid': '12407575', 'type': 'BACKGROUND', 'citation': 'Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. doi: 10.1053/jhep.2002.36806.'}, {'pmid': '9121257', 'type': 'BACKGROUND', 'citation': 'Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.'}, {'pmid': '12512034', 'type': 'BACKGROUND', 'citation': 'Ghany MG, Kleiner DE, Alter H, Doo E, Khokar F, Promrat K, Herion D, Park Y, Liang TJ, Hoofnagle JH. Progression of fibrosis in chronic hepatitis C. Gastroenterology. 2003 Jan;124(1):97-104. doi: 10.1053/gast.2003.50018.'}, {'pmid': '10644270', 'type': 'BACKGROUND', 'citation': 'Seeff LB, Miller RN, Rabkin CS, Buskell-Bales Z, Straley-Eason KD, Smoak BL, Johnson LD, Lee SR, Kaplan EL. 45-year follow-up of hepatitis C virus infection in healthy young adults. Ann Intern Med. 2000 Jan 18;132(2):105-11. doi: 10.7326/0003-4819-132-2-200001180-00003.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The plasma donors were primarily chosen from healthy farmers and agricultural workers living in a remote small city in the Northwest China.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All these patients had a definite history of regular plasma donations with repeated blood cell re-transfusions.\n* The Hepatitis C Virus antibody was positive.\n* All patients did not receive interferon therapy before being recruited.\n\nExclusion Criteria:\n\n* Patients with evidences for other forms of liver diseases.\n* The coinfection with hepatitis B virus or other virus.'}, 'identificationModule': {'nctId': 'NCT02011932', 'briefTitle': 'Prospective Observational Study of Disease Progression in Chronic Hepatitis C', 'organization': {'class': 'OTHER', 'fullName': 'Beijing YouAn Hospital'}, 'officialTitle': 'Observational Study of Disease Progression and Risk Factors in Chronic Hepatitis C Caused by Plasma Donation', 'orgStudyIdInfo': {'id': 'BJYAH-2011-045'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healthy volunteers'}, {'label': 'Chronic hepatitis C'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Zhongping Duan, Ph.D.,M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing YouAn Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing YouAn Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Dean,Professor,Chief Physician', 'investigatorFullName': 'Zhongping Duan', 'investigatorAffiliation': 'Beijing YouAn Hospital'}}}}