Ignite Creation Date:
2025-12-24 @ 10:59 PM
Ignite Modification Date:
2026-01-03 @ 6:30 PM
Study NCT ID:
NCT01679769
Status:
COMPLETED
Last Update Posted:
2015-11-06
First Post:
2012-09-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'liver biopsy samples and blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 818}, 'targetDuration': '2 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-04', 'studyFirstSubmitDate': '2012-09-01', 'studyFirstSubmitQcDate': '2012-09-01', 'lastUpdatePostDateStruct': {'date': '2015-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of staging fibrosis with a combination of non-invasive parameters compared to liver biopsy', 'timeFrame': 'within two weeks after liver biopsy'}], 'secondaryOutcomes': [{'measure': 'Evaluation of staging inflammation with a combination of non-invasive parameters compared to liver biopsy', 'timeFrame': 'within two weeks after liver biopsy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Chronic Hepatitis B']}, 'descriptionModule': {'briefSummary': 'The aim of our study is to evaluate liver fibrosis using biochemical markers, FibroScan, and radiology methods in patients with chronic hepatitis B in mainland China.', 'detailedDescription': 'Up to Nov, 2015, total of 818 patients with chronic HBV infection had been enrolled in the study. Paired blood and liver biopsy specimen had been collected. The serum samples stored at -80 degree Celsius. All the liver biopsy samples were judged by three pathology experts, according to Ishak standard.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with chronic hepatitis B or compensated cirrhosis due to chronic hepatits B virus (HBV) infection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of chronic hepatitis B or compensated cirrhosis due to chronic hepatitis B virus infection\n* agree to have liver biopsy\n\nExclusion Criteria:\n\n* clinical diagnosis of decompensated cirrhosis due to hepatitis B virus or inactive carrier\n* liver diseases due to other origin'}, 'identificationModule': {'nctId': 'NCT01679769', 'briefTitle': 'Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic Hepatitis B', 'organization': {'class': 'OTHER', 'fullName': 'Peking University First Hospital'}, 'officialTitle': 'Prospective Study In Noninvasive Evaluation of Hepatic Fibrosis in Chronic', 'orgStudyIdInfo': {'id': '2012-455'}, 'secondaryIdInfos': [{'id': '81170386', 'type': 'OTHER_GRANT', 'domain': 'from The National Natural Science Foundation of China'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100034', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University First Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Guiqiang Wang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University First Hospital'}, {'name': 'Hong Zhao, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Peking University First Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking University First Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Beijing Municipal Science & Technology Commission', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Guiqiang Wang', 'investigatorAffiliation': 'Peking University First Hospital'}}}}