Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects With Immune Thrombocytopenia for 6 Months

  • STATUS
    Recruiting
  • End date
    May 15, 2025
  • participants needed
    72
  • sponsor
    Dova Pharmaceuticals
Updated on 14 August 2021
thrombocytopenia
avatrombopag

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

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 to the open label extension phase which will last 2 years.

Details
Condition IDIOPATHIC THROMBOCYTOPENIC PURPURA, Autoimmune disease, Immune Thrombocytopenia, Idiopathic Thrombocytopenic Purpura (ITP), Thrombocytopenic, autoimmune thrombocytopenia
Treatment Placebo, Avatrombopag
Clinical Study IdentifierNCT04516967
SponsorDova Pharmaceuticals
Last Modified on14 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female participants 1 and <18 years of age at Screening 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 <30109/L with no single count >35109/L in the screening period

Exclusion Criteria

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
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