Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-01-01 @ 9:10 PM
Study NCT ID:
NCT03391856
Status:
TERMINATED
Last Update Posted:
2020-09-25
First Post:
2018-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prolonged Isolated Thrombocytopenia After Allo-SCT : N-acetyl-L-cysteine (NAC) Versus Supportive Therapy
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': 'D000111', 'term': 'Acetylcysteine'}, {'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'whyStopped': 'protocol changed', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-23', 'studyFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2018-01-04', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'response rate', 'timeFrame': '30 days after the start of enrollement', 'description': 'rate of response after 30 days of treatment'}], 'secondaryOutcomes': [{'measure': 'overall survival', 'timeFrame': 'the day of last follow-up', 'description': 'survival proportion at the last followup after transplantation'}, {'measure': 'non-relapse mortality', 'timeFrame': 'the day of last follow-up', 'description': 'non-relapse mortality at the last followup after transplantation'}, {'measure': 'grade 2-4 acute graft versus host disease', 'timeFrame': 'day 100 after transplant', 'description': 'grade 2-4 aGVHD at day 100 after transplant'}, {'measure': 'chronic graft versus host disease', 'timeFrame': 'the day of last follow-up', 'description': 'chronic graft versus host disease at the day of last follow-up'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thrombocytopenia', 'Stem Cell Transplant Complications']}, 'descriptionModule': {'briefSummary': 'Isolated prolonged thrombocytopenia (PT) is a common complication after allogeneic stem cell transplantation with significant poor prognosis. No standard treatment is available. The current study assigned PT randomly to 2 arms: intervention arm with N-acetyl-L-cysteine (NAC) and control arm with supportive therapy.This is a prospective randomized controlled study.', 'detailedDescription': '1. patients diagnosed with PT at day 60 post transplant will be randomized assigned to intervention arm (NAC) or controlled arm (supportive therapy: prophylactic platelet transfusion was given when platelet count \\<20000/ul.)\n2. Response will be evaluated at day 90. Response was defined as platelet recovery to \\>= 20000/ul for 7 consecutive days without transfusion support during the enrollment period. All the other patients not achieved above criteria was defined as no response.\n3. For those without response in both arms, patients will received NAC plus recombinant human thrombopoietin (rhTPO) for an additional 30 days. rhTPO was given at 300IU/kg/d for 28 consecutive days or platelet \\> 50000/ul independent of platelet transfusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '14 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age\\>= 14 years\n* diagnosed as PT (defined as platelet count in peripheral blood never achieve 20000/miro-liter for 7 consecutive days without transfusion at day 60 post transplantation)\n* serum creatine level \\< ULN (upper limit of normal), serum ALT/AST /TBil\\<=2 ULN\n* without active CMV/EBV/ADV reactivation, active GVHD, without relapse or minimal residual disease at enrollment\n\nExclusion Criteria:\n\n* history of asthma\n* allergy to NAC\n* refuse to participate'}, 'identificationModule': {'nctId': 'NCT03391856', 'briefTitle': 'Prolonged Isolated Thrombocytopenia After Allo-SCT : N-acetyl-L-cysteine (NAC) Versus Supportive Therapy', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'A Prospective Randomized Controlled Study for Intervention of Prolonged Isolated Thrombocytopenia After Allogeneic Hematopoietic Stem Cell Transplantation: N-acetyl-L-cysteine (NAC) Versus Supportive Therapy', 'orgStudyIdInfo': {'id': '2017PHB220'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intervention arm', 'description': 'NAC 400mg p.o tid from day 60 to day 90 post transplant', 'interventionNames': ['Drug: N-acetyl-L-cysteine (NAC)']}, {'type': 'OTHER', 'label': 'controlled arm', 'description': 'Supportive therapy including platelet infusion:prophylactic platelet transfusion was given when platelet count \\<20000/ul', 'interventionNames': ['Other: supportive therapy']}], 'interventions': [{'name': 'N-acetyl-L-cysteine (NAC)', 'type': 'DRUG', 'description': 'NAC treatment for PT: 400mg p.o tid from day 60 to 90 post transplant', 'armGroupLabels': ['intervention arm']}, {'name': 'supportive therapy', 'type': 'OTHER', 'description': 'prophylactic platelet transfusion was given when platelet count \\<20000/ul', 'armGroupLabels': ['controlled arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiao-Jun Huang, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peiking University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, {'name': 'Nanfang Hospital, Southern Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Peking University Institute of Hematology', 'investigatorFullName': 'Xiaojun Huang,MD', 'investigatorAffiliation': "Peking University People's Hospital"}}}}