Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-31 @ 4:25 AM
Study NCT ID:
NCT04737850
Status:
COMPLETED
Last Update Posted:
2025-07-18
First Post:
2021-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016553', 'term': 'Purpura, Thrombocytopenic, Idiopathic'}], 'ancestors': [{'id': 'D011696', 'term': 'Purpura, Thrombocytopenic'}, {'id': 'D011693', 'term': 'Purpura'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D057049', 'term': 'Thrombotic Microangiopathies'}, {'id': 'D013921', 'term': 'Thrombocytopenia'}, {'id': 'D001791', 'term': 'Blood Platelet Disorders'}, {'id': 'D000095542', 'term': 'Cytopenia'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012877', 'term': 'Skin Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000614661', 'term': 'hetrombopag'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-06-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2021-01-17', 'studyFirstSubmitQcDate': '2021-02-03', 'lastUpdatePostDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the main parameters in population PK/PD modeling in Part A', 'timeFrame': 'from baseline to Week 2', 'description': 'Peak Plasma Concentration (Cmax)'}, {'measure': 'the proportion of patients with a platelet count ≥50×10^9/L at week 10.', 'timeFrame': 'from baseline to Week 10', 'description': 'efficacy in part B'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ITP'], 'conditions': ['Immune Thrombocytopenia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the efficacy, safety of Hetrombopag in children with previously treated chronic immune thrombocytopenia who are between 6 and 17 years of age. This is a 2 part study. In part A, patients will receive Hetrombopag for 8 weeks. In part B, all patients will receive Hetrombopag for 24 weeks.', 'detailedDescription': 'This is a two-part, double-blind, randomized, placebo-controlled, and open-label Phase III study to investigate the efficacy, safety of Hetrombopag in pediatric patients with previously treated chronic ITP. In Part A, patients will receive Hetrombopag for 8 weeks. After completing Part A, patients will begin Part B, in which they will be randomized to receive Hetrombopag or placebo in a 12 week double-blind, placebo-controlled treatment period, following an open-label 12 week treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥ 6 years old and ≤ 17 years old,both sexes.\n2. Part A:Confirmed diagnosis of ITP ≥6months; Part B: Confirmed diagnosis of ITP ≥12months;Platelets \\<30×10\\^9/L twice in a row,and platelets \\<30×10\\^9/L before taking the medicine.\n3. Subjects who are refractory or have relapsed after at least one prior ITP therapy.\n4. Birth control during and 28 days after the trial.\n5. Written informed consent must be obtained from the patient's guardian and accompanying informed assent from the patient (for children over 8 years old).\n\nExclusion Criteria:\n\n1. No evidence of other causes of thrombocytopenia.\n2. Diagnosis as Evans or Wiskott-Aldrich comprehensive.\n3. Patients with any prior history of arterial or venous thrombosis, or diagnosis as thrombophilia.\n4. Suffering from serious, progressive, uncontrolled kidney, liver, gastrointestinal, endocrine, lung, heart, nervous system, brain, or mental illness.\n5. ALT, AST, or ALP\\> 1.5 x upper limit of normal (ULN), DBLI, or Scr \\> 1.2 x upper limit of normal (ULN).\n6. Active HIV or HCV-Ab positive,HBsAg positive.\n7. PT result exceeds normal by more than ±3s, APTT result exceeds normal by more than ±10s\n8. Participated in clinical trials of other drugs (received experimental drugs) within 3 months prior to medication.\n9. The inestigators determined that other conditions were inappropriate for participation in this clinical trial."}, 'identificationModule': {'nctId': 'NCT04737850', 'briefTitle': 'Hetrombopag for Pediatric Patients With Chronic Immune Thrombocytopenia', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'Safety and Efficacy of Hetrombopag in Children and Adolescents With Chronic Primary Immune Thrombocytopenia：a Randomized, Multicenter, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': 'HR-TPO-ITP-III-PED'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PartA, open-label', 'description': 'Hetrombopag plus standard of care', 'interventionNames': ['Drug: Hetrombopag']}, {'type': 'EXPERIMENTAL', 'label': 'PartB, double-blind treatment group', 'description': 'Hetrombopag plus standard of care', 'interventionNames': ['Drug: Hetrombopag']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator', 'description': 'Placebo plus standard of care Part B, double-blind treatment group', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Hetrombopag', 'type': 'DRUG', 'description': 'Thrombopoietin receptor agonist', 'armGroupLabels': ['PartA, open-label', 'PartB, double-blind treatment group']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo with no active pharmaceutical ingredient', 'armGroupLabels': ['Placebo Comparator']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Beijing children's hospital .Capital medical university", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}