Ignite Creation Date:
2025-12-24 @ 2:34 PM
Ignite Modification Date:
2026-01-06 @ 2:48 PM
Study NCT ID:
NCT03554759
Status:
TERMINATED
Last Update Posted:
2024-10-21
First Post:
2018-05-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533238', 'term': 'avatrombopag'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Study was terminated early due to enrollment challenges', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-05-31', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in platelet count', 'timeFrame': 'Up to 8 days after the last dose of avatrombopag.'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients who received a platelet transfusion', 'timeFrame': 'From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag'}, {'measure': 'Occurrence of adverse events', 'timeFrame': 'From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True}, 'conditionsModule': {'keywords': ['Chronic Liver Disease', 'Low Platelet Count'], 'conditions': ['Thrombocytopenia']}, 'descriptionModule': {'briefSummary': 'Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.', 'detailedDescription': 'Data (e.g. type of procedure, platelet count, etc.) will be collected retrospectively or prospectively from patient visits occurring within approximately 7 calendar days prior to the first dose of avatrombopag, on Procedure Day, on Discharge Day, and from any clinic visit performed up to 30 days post-procedure. All treatment decisions and clinical assessments will be at the discretion of the treating physician per routine medical care and are not mandated by study design or protocol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients ≥18 years of age who have thrombocytopenia associated with chronic liver disease and are planned for or underwent treatment with avatrombopag prior to a procedure.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has thrombocytopenia associated with chronic liver disease and is planned for or underwent treatment with avatrombopag prior to a procedure\n* Patient provides written informed consent\n\nMinimum Data for Retrospective Enrollment\n\n* Platelet count from approximately 7 days prior to starting avatrombopag\n* Platelet count on Procedure Day'}, 'identificationModule': {'nctId': 'NCT03554759', 'briefTitle': 'Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sobi, Inc.'}, 'officialTitle': 'An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure', 'orgStudyIdInfo': {'id': 'AVA-CLD-401'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Avatrombopag', 'type': 'DRUG', 'description': 'Avatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Dova Site', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '93534', 'city': 'Lancaster', 'state': 'California', 'country': 'United States', 'facility': 'Dova Site', 'geoPoint': {'lat': 34.69804, 'lon': -118.13674}}, {'zip': '90048', 'city': 'Los 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