Ignite Creation Date:
2025-12-24 @ 3:58 PM
Ignite Modification Date:
2025-12-25 @ 2:01 PM
Study NCT ID:
NCT05143892
Status:
UNKNOWN
Last Update Posted:
2022-12-23
First Post:
2021-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Avatrombopag to Promote Platelet Engraftment After Allo-HSCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}], 'ancestors': [{'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D000095542', 'term': 'Cytopenia'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533238', 'term': 'avatrombopag'}, {'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-28', 'size': 325497, 'label': 'Study Protocol, Statistical Analysis Plan, and Informed Consent Form', 'hasIcf': True, 'hasSap': True, 'filename': 'Prot_SAP_ICF_000.pdf', 'typeAbbrev': 'Prot_SAP_ICF', 'uploadDate': '2021-11-16T08:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into avatrombopag group or supportive care group at the ratio of 1:1.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2023-11-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-12-21', 'studyFirstSubmitDate': '2021-11-21', 'studyFirstSubmitQcDate': '2021-11-21', 'lastUpdatePostDateStruct': {'date': '2022-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of participants whose PLT reaches ≥ 20*10^9/L without the need for PLT transfusion.', 'timeFrame': 'up to 4 weeks', 'description': 'Accumulated platelet engraftment ratio'}], 'secondaryOutcomes': [{'measure': 'Percentage of participants whose PLT reaches ≥ 50*10^9/L without the need for PLT transfusion.', 'timeFrame': 'up to 4 weeks', 'description': 'Accumulated complete platelet engraftment ratio'}, {'measure': 'The time to achieve PLT ≥ 20*10^9/L without the need of PLT transfusion for consecutive 7 days (Defined as the first day when PLT ≥ 20×10^9/L without relying on platelet transfusion for 7 consecutive days )', 'timeFrame': 'up to 4 weeks', 'description': 'time duration of platelet engraftment'}, {'measure': 'Volume of PLT transfusion', 'timeFrame': 'up to 4 weeks', 'description': 'Volume of PLT transfusion'}, {'measure': 'Hematopoietic reconstruction condition', 'timeFrame': 'up to 4 weeks', 'description': 'absolute neutrophils, hemoglobin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Avatrombopag', 'thrombocytopenia', 'allogenic hematopoietic stem cell transplantation', 'engraftment'], 'conditions': ['Platelet Disorder']}, 'referencesModule': {'references': [{'pmid': '36185780', 'type': 'BACKGROUND', 'citation': 'Zhou M, Qi J, Gu C, Wang H, Zhang Z, Wu D, Han Y. Avatrombopag for the treatment of thrombocytopenia post hematopoietic stem-cell transplantation. Ther Adv Hematol. 2022 Sep 28;13:20406207221127532. doi: 10.1177/20406207221127532. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to evaluate the efficacy and safety of avatrombopag for the promotion of platelet engraftment after Allo-HSCT.', 'detailedDescription': "Patients with thrombocytopenia (PLT\\<20×10\\^9/L) after allogenic hematopoietic stem cell transplantation (Allo-HSCT) who meet Eligibility Criteria were assigned into the avatrombopag group for 4 weeks' treatment."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female, aged between 18-60 years;\n* PLT\\<20×10\\^9/L after 14 days of allo-HSCT;\n* Expected survival time \\> 3 months;\n* ECOG performance status 0-2;\n* Agree to receive the treatment of avatrombopag after Allo-HSCT and must sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant or lactating;\n* With severe and uncontrollable infection;\n* With graft-versus-host disease (GVHD) with steroid resistance;\n* With thrombotic microangiopathy; With active thromboembolism requiring anticoagulation\n* With detected disease recurrence due to chimerism by flow cytometry;\n* With chronic active hepatitis B and C virus infection;\n* With secondary or multiple transplantation, or multiple organ transplantation;\n* With severe heart disease, lung disease, diabetes and metabolic diseases;\n* HIV positive;\n* With a history of PLT dysfunction or bleeding disorders\n* With the active hepatic venous occlusion disease, or a history of clinically significant hepatic venous occlusion disease (The disease was defined as the abnormal condition of painful hepatomegaly after transplantation with bilirubin ≥ 6.0 mg/dL);\n* With progressive solid tumor;\n* With severe bleeding requiring transfusion of more than 2 units of red blood cells, or sudden drop of blood cell volume ≥10% within 7 days prior to screening;\n* With any other clinical trial of investigational product or device within 30 days prior to the baseline visit, except for observational study;\n* With treatment of thrombopoietin receptor agonist (TPO-RA) one month before enrollment;\n* Deemed unsuitable for enrollment by the investigator.'}, 'identificationModule': {'nctId': 'NCT05143892', 'briefTitle': 'Avatrombopag to Promote Platelet Engraftment After Allo-HSCT', 'organization': {'class': 'OTHER', 'fullName': 'The First Affiliated Hospital of Soochow University'}, 'officialTitle': 'Study on Avatrombopag for the Promotion of Platelet Engraftment After Allogeneic Hematopoietic Stem Cell Transplantation', 'orgStudyIdInfo': {'id': 'SOOCHOW-HY-2021-11'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Avatrombopag', 'description': "In the 4-weeks'study,the initial dose of avatrombopag is 20 mg/d. If the patient's PLT count remains less than 20\\*10\\^9/L after one week, the maximum dose was increased to 40 mg/d. Avatrombopag will be taken orally with food.", 'interventionNames': ['Drug: Avatrombopag']}, {'type': 'OTHER', 'label': 'Supportive care', 'description': 'Patients in this arm receive same treatment as in the avatrombopag group,except any TPO-RAs or recombinant human thrombopoietin.', 'interventionNames': ['Other: Supportive care']}], 'interventions': [{'name': 'Avatrombopag', 'type': 'DRUG', 'otherNames': ['Doptelet'], 'description': 'Avatrombopag administered at the described frequency to achieve a target platelet count', 'armGroupLabels': ['Avatrombopag']}, {'name': 'Supportive care', 'type': 'OTHER', 'otherNames': ['support'], 'description': 'Supportive care other than TPO-RAs or recombinant human thrombopoietin.', 'armGroupLabels': ['Supportive care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '215000', 'city': 'Suzhou', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Meng Zhou, MD', 'role': 'CONTACT', 'email': 'zhoumeng@suda.edu.cn', 'phone': '+8615606133002'}], 'facility': 'The first affiliated hospital of Soochow University', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}], 'centralContacts': [{'name': 'Yue Han, MD PhD', 'role': 'CONTACT', 'email': 'hanyue@suda.edu.cn', 'phone': '(0086)51267781856'}, {'name': 'Depei Wu, MD PhD', 'role': 'CONTACT', 'email': 'drwudepei@163.com', 'phone': '(0086)51267781856'}], 'overallOfficials': [{'name': 'Yue Han', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The First Affiliated Hospital of Soochow University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The First Affiliated Hospital of Soochow University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of hematology department', 'investigatorFullName': 'HAN Yue', 'investigatorAffiliation': 'The First Affiliated Hospital of Soochow University'}}}}