Status:
ACTIVE_NOT_RECRUITING
Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
Lead Sponsor:
Sobi, Inc.
Conditions:
Immune Thrombocytopenia
Eligibility:
All Genders
1-17 years
Phase:
PHASE3
Brief Summary
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
Detailed Description
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 t...
Eligibility Criteria
Inclusion
- 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.
- Participant has an average of 2 platelet counts \<30×10\^9/L with no single count \>35×10\^9/L in the screening period
Exclusion
- 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.
Key Trial Info
Start Date :
March 5 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 28 2025
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT04516967
Start Date
March 5 2021
End Date
October 28 2025
Last Update
October 1 2025
Active Locations (62)
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1
Site 112
Phoenix, Arizona, United States, 85016
2
Site 103
Long Beach, California, United States, 90806
3
Site 119
Orange, California, United States, 92868
4
Site 109
Sacramento, California, United States, 95817