Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-25 @ 7:52 PM
Study NCT ID:
NCT06376435
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-19
First Post:
2024-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016609', 'term': 'Neoplasms, Second Primary'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-18', 'studyFirstSubmitDate': '2024-04-11', 'studyFirstSubmitQcDate': '2024-04-18', 'lastUpdatePostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of patients recovered to 100×109/L', 'timeFrame': '14 days after starting treatment with the study drug', 'description': 'The proportion of patients who recovered to 100×109/L within 14 days after starting treatment with the drug was studied'}], 'secondaryOutcomes': [{'measure': 'The proportion of patients recovered to 75×109/L', 'timeFrame': 'up to 2 months', 'description': 'The proportion of patients who recovered to 75×109/L after starting treatment with the drug was studied'}, {'measure': 'Time for platelet recovery to 100×109/L', 'timeFrame': 'up to 2 months', 'description': 'Study the time for platelet recovery to 100×109/L after drug initiation'}, {'measure': 'Proportion of patients with treatment delay or dose reduction', 'timeFrame': 'up to 2 months', 'description': 'Proportion of patients with delayed or reduced dose of radiotherapy, chemotherapy, immunosuppressants, etc'}, {'measure': 'TRAE', 'timeFrame': 'up to 2 months', 'description': 'Study drug-related adverse reactions'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cancer, Therapy-Related']}, 'descriptionModule': {'briefSummary': 'The objective of this study was to observe and evaluate the efficacy and safety of hexapopal ethanolamine tablets in the treatment of synchronous/sequential radioimmunoinduced thrombocytopenia in the real world.\n\nThe subjects of this study were patients with solid malignant tumors who had received radioimmunoinduced thrombocytopenia.\n\nThis study will retrospectively and prospectively collect real-world data related to investigational drugs, and will observe 500 patients to observe the diagnosis and treatment pattern of radiochemo-induced thrombocytopenia. The study included a screening period (no more than one week) and a treatment period (at least two cycles).Participants meeting protocol inclusion criteria were defined as having platelet values \\< 100×109/L during radioimmunotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with solid malignancies undergoing radiotherapy/chemotherapy/immunosuppressant induced thrombocytopenia', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Understand the research procedure and voluntarily sign the informed consent to participate in the study\n* Subjects ≥18 years of age receiving synchronous/sequential chemotherapeutic therapy\n* Patients with platelet count ≤100×109/L or platelet count decrease ≥ 50×109/L or platelet count \\> 100×109/L but need to be prophylaxis with hexapopethanolamine tablets\n* Researchers believe that subjects need to be treated with hexapopal.\n\nExclusion Criteria:\n\n* The subjects are conducting clinical intervention studies\n* Patients with known or expected allergy or intolerance to the active ingredient or excipient of hexapopar\n* Pregnant or lactating women\n* Other conditions deemed unsuitable for inclusion in the study by the researcher.'}, 'identificationModule': {'nctId': 'NCT06376435', 'briefTitle': 'A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia', 'organization': {'class': 'OTHER', 'fullName': 'Hebei Medical University Fourth Hospital'}, 'officialTitle': 'A Multicentre Real-world Study of Heptapopal Ethanolamine Tablets in Concurrent/Sequential Radioimmunoinduced Thrombocytopenia', 'orgStudyIdInfo': {'id': 'HBHQ-CTIT-RWS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Single drug group', 'interventionNames': ['Drug: Herombopag Olamine Tablets']}, {'label': 'combined rhTPO group', 'interventionNames': ['Drug: Herombopag Olamine Tablets']}, {'label': 'combined IL-11 group', 'interventionNames': ['Drug: Herombopag Olamine Tablets']}], 'interventions': [{'name': 'Herombopag Olamine Tablets', 'type': 'DRUG', 'description': 'Herombopag Olamine；combined rhTPO;combined IL-11', 'armGroupLabels': ['Single drug group', 'combined IL-11 group', 'combined rhTPO group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hebei Medical University Fourth Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'study principal investigator', 'investigatorFullName': 'Jun wang', 'investigatorAffiliation': 'Hebei Medical University Fourth Hospital'}}}}