Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-03 @ 2:37 PM
Study NCT ID:
NCT03091556
Status:
UNKNOWN
Last Update Posted:
2017-03-27
First Post:
2017-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056486', 'term': 'Chemical and Drug Induced Liver Injury'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D064420', 'term': 'Drug-Related Side Effects and Adverse Reactions'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D011041', 'term': 'Poisoning'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Samples With DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-03-25', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-21', 'studyFirstSubmitDate': '2017-03-21', 'studyFirstSubmitQcDate': '2017-03-21', 'lastUpdatePostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Disease progression of early liver injuries caused by XLGB Pill, i.e. death, liver failure, chronic DILI, recovery.', 'timeFrame': '8 weeks', 'description': 'Disease progression of early liver injuries caused by XLGB Pill, i.e. death, liver failure, chronic DILI, recovery.'}], 'primaryOutcomes': [{'measure': 'The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Pill.', 'timeFrame': 'participants will be followed duration intake of XLGB Pill, an expected average within 8 weeks', 'description': 'The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Pill.'}], 'secondaryOutcomes': [{'measure': 'Clinical features of early liver injuries caused by XLGB Pill assessed by serum parameters of liver function.', 'timeFrame': 'participants will be followed duration intake of XLGB Pill, an expected average of 8 weeks', 'description': 'Clinical features of early liver injuries caused by XLGB Pill assessed by serum parameters of liver function.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug-Induced Liver Injury'], 'conditions': ['Drug-Induced Liver Injury']}, 'descriptionModule': {'briefSummary': 'This is a prospective registry study to surveil early liver injuries caused by Xianlin Gubao Pill (XLGB Pill) through a non-intervention observational way. And attempt to establish a predictive model to screen susceptibilities to XLGB Pill.', 'detailedDescription': 'The primary objectives of this study include:\n\n(i) The detection of patients with serum liver biochemistry abnormalities within 8 weeks after intake of XLGB Pill; (ii) The record of overall individuals with demographics, underlying diseases, physical status, medication information, clinical laboratory index, and so on; (iii) The specimen collection of surveiled individuals. (iv) The attempt to establish a predictive model to screen susceptibilities to XLGB Pill.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'community sample and primary care clinic.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Individuals in accordance with indications for XLGB Pill, including symptoms of osteoporosis;\n2. The age range of 18 to 70 years；\n3. Individuals taking XLGB Pill over 2 weeks;\n4. Abnormalities of serum liver biochemistry achieving one of the criteria as follows:\n\n (i) alanine aminotransaminase (ALT) or aspartate transaminase (AST) ≥2 folds of upper limit of normal (ULN); (ii) total bilirubin (TBiL) ≥ 2 ULN; (iii) alkaline phosphatase (ALP) ≥ 2 ULN;\n5. Individuals can provide informed consent form.\n\nExclusion Criteria:\n\n1. Individuals without indications for XLGB Pill;\n2. Unconformity to the XLGB Pill drug label;\n3. Individual taking XLGB Pill less than 2 weeks;\n4. Individuals taking other hepatotoxic drugs combined with XLGB Pill, simultaneously;\n5. Unconformity to the diagnostic standard for herb-induced liver injury (the Guideline for Diagnosis and Treatment of Herb-induced Liver Injury, RPGIP-2016CN003）.'}, 'identificationModule': {'nctId': 'NCT03091556', 'briefTitle': 'Surveillance for Early Liver Injuries Caused by Xianlin Gubao Pill.', 'organization': {'class': 'OTHER', 'fullName': 'Beijing 302 Hospital'}, 'officialTitle': 'A Registry Study to Surveil Early Liver Injuries Caused by Xianlin Gubao Pill (XLGB Pill).', 'orgStudyIdInfo': {'id': '302-xxh-XLGBP'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The individuals taking XLGB Pill', 'description': 'The overall individuals taking XLGB Pill with recommended dosage and achieving the inclusion criteria.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100039', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': '302 Military Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Xiao-he Xiao', 'role': 'CONTACT', 'email': 'pharmacy302xxh@126.com', 'phone': '+86 66933322'}, {'name': 'Jia-bo Wang', 'role': 'CONTACT', 'email': 'pharm_sci@126.com', 'phone': '+86 66933323'}], 'overallOfficials': [{'name': 'Xiao-he Xiao', 'role': 'STUDY_DIRECTOR', 'affiliation': '302 Military Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing 302 Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Xiaohe Xiao', 'investigatorAffiliation': 'Beijing 302 Hospital'}}}}