Overview

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

Status:
Recruiting

Trial end date:
2025-05-15

Target enrollment:
0

Participant gender:
All

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

Phase:

Phase 3

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Dova Pharmaceuticals

Criteria

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 <30×109/L with no single count
>35×109/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.