Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for ≥6 Months
Completed · Phase 3 · Has a placebo group
Conditions studied: Immune Thrombocytopenia
In brief
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
Key facts
- Study ID
- NCT04516967
- Run by
- Sobi, Inc.
- People needed
- 75
- Starts
- 2021-03-05
- Expected to finish
- 2025-10-28
- Last updated by the study team
- 2026-06-03
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Site 103 — Long Beach, California, United States
- Site 119 — Orange, California, United States
- Site 109 — Sacramento, California, United States
- Site 101 — San Francisco, California, United States
- Site 111 — Aurora, Colorado, United States
- Site 120 — Wilmington, Delaware, United States
- Site 117 — Gainesville, Florida, United States
- Site 116 — Atlanta, Georgia, United States
- Site 107 — Peoria, Illinois, United States
- Site 104 — Boston, Massachusetts, United States
- Site 105 — Minneapolis, Minnesota, United States
- Site 114 — Jackson, Mississippi, United States
- Site 102 — Las Vegas, Nevada, United States
- Site 108 — Morristown, New Jersey, United States
- Site 118 — Charlotte, North Carolina, United States
- Site 113 — Durham, North Carolina, United States
- Site 106 — Columbus, Ohio, United States
- Site 121 — Philadelphia, Pennsylvania, United States
- Site 110 — Providence, Rhode Island, United States
- Site 115 — Houston, Texas, United States
- Site 201 — Toulouse, Occitanie, France
- Site 202 — Paris, Île-de-France Region, France
- Site 301 — Freiburg im Breisgau, Baden-Wurttemberg, Germany
- Site 302 — Hamburg, Free and Hanseatic City of Hamburg, Germany
- Site 112 — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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