Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 10:44 PM
Study NCT ID:
NCT04516967
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-01
First Post:
2020-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
Sponsor:
Organization:
Raw JSON
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the Core Phase, in the absence of rescue therapy.'}, {'measure': 'Platelet Response at Day 8', 'timeFrame': 'Day 8', 'description': 'The proportion of subjects with a platelet count ≥50×10\\^9/L at day 8, in the absence of rescue therapy.'}, {'measure': 'Percentage of Weeks Platelet Count Between ≥50×10^9/L and ≤150×10^9/L', 'timeFrame': '12 weeks of treatment', 'description': 'The percentage of weeks subjects have a platelet count between ≥50×10\\^9/L and ≤150×10\\^9/L, during 12 weeks of treatment in the Core Phase, in the absence of rescue therapy.'}, {'measure': 'Rescue Medications', 'timeFrame': '12 weeks of treatment', 'description': 'The proportion of subjects who require rescue medications during 12 weeks of treatment in the Core Phase of the study.'}, {'measure': 'Incidence of Any Bleeding Event (WHO Grade 1-4)', 'timeFrame': '12 weeks of treatment', 'description': 'Overall incidence of bleeding events associated with ITP measured using the WHO Bleeding Scale (Grade 1-4).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ITP'], 'conditions': ['Immune Thrombocytopenia']}, 'referencesModule': {'references': [{'pmid': '40418942', 'type': 'DERIVED', 'citation': 'Grace RF, Leblebisatan G, Aydinok Y, Unal S, Grainger JD, Zhang J, Smallwood L, de Leon E, Jamieson BD; AVA-PED-301 Study Group. Avatrombopag for the treatment of children and adolescents with immune thrombocytopenia (AVA-PED-301): a multicentre, randomised, double-blind, placebo-controlled, phase 3b study. Lancet Haematol. 2025 Jul;12(7):e494-e504. doi: 10.1016/S2352-3026(25)00107-3. Epub 2025 May 23.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 3b Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia for ≥6 Months', 'detailedDescription': 'Subjects will be randomized in to blinded therapy of avatrombopag or placebo in a 3:1 ratio for a period of 12 weeks. Subjects who complete the 12 week treatment period and are eligible may continue to the open label extension phase which will last 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '1 Year', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female participants ≥1 and \\<18 years of age at Screening and Baseline with a diagnosis of primary ITP for ≥6 months duration and has had an insufficient response to a previous treatment, in the opinion of the Investigator.\n* Participant has an average of 2 platelet counts \\<30×10\\^9/L with no single count \\>35×10\\^9/L in the screening period\n\nExclusion Criteria:\n\n* Participants must not have a known history of secondary ITP, any history of arterial or venous thrombosis, including partial or complete thrombosis, known inherited thrombocytopenia, a history of myelodysplastic syndrome (MDS) or known history of congenital heart abnormalities or arrhythmias.'}, 'identificationModule': {'nctId': 'NCT04516967', 'briefTitle': 'Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sobi, Inc.'}, 'officialTitle': 'Randomized, Double-blind, Placebo-controlled Study With Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months', 'orgStudyIdInfo': {'id': 'AVA-PED-301'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Avatrombopag Double Blind', 'description': 'Study is 3:1 randomization ratio (avatrombopag to placebo). 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Investigational product administered orally once daily for 12 weeks', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Avatrombopag Open Label Extension', 'description': 'Investigational product administered orally for up to 2 years.', 'interventionNames': ['Drug: Avatrombopag']}], 'interventions': [{'name': 'Avatrombopag', 'type': 'DRUG', 'otherNames': ['Doptelet'], 'description': 'Oral avatrombopag tablet or sprinkle capsule', 'armGroupLabels': ['Avatrombopag Open Label Extension', 'Experimental: Avatrombopag Double Blind']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo comparator tablet or sprinkle capsule', 'armGroupLabels': ['Placebo Comparator:Placebo Double Blind']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85016', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 112', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '90806', 'city': 'Long Beach', 'state': 'California', 'country': 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