Dova Study for Children with Immune Thrombocytopenia (ITP)

AddtoAny
Share:

WATCH THIS PAGE

Subscribe to be notified of changes or updates to this page.

15 + 1 =
Solve this simple math problem and enter the result. E.g. for 1+3, enter 4.

The Dova study is for children below 18 years with primary Immune Thrombocytopenia (ITP) who have had an insufficient response to previous treatment. The goal of the study is to see if the study drug, Avatrombopag can safely increase platelet counts and improve symptoms for people with ITP. Avatrombopag is an investigational medication designed to make your body produce more platelets. You may be able to join the study if you are:

  • 1 year or older but below 18 years of age
  • Diagnosed with primary ITP for at least 6 months.

Other study requirements will apply.

Eligibility & Criteria

IRB #:
20-018028
Official Title:
A Phase 3b, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial with an Open-label Extension Phase to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Thrombocytopenia in Pediatric Subjects with Immune Thrombocytopenia (ITP) for greater than or equal to 6 Months
Study Phase:
Not Applicable
Eligible Age Range:
1 - 17 Years
Gender:
All
Study Categories:

Visit Criteria

If you agree to take part, your study participation will last for 29 months and will involve 2 phases, the Core and Extension Phase. The Core Phase lasts for 5 months and involves 15 study visits. The Extension Phase lasts for 2 years and involves 25 study visits.

You will need to take the study drug, Avatrombopag or placebo (which has no active ingredients) by mouth, once a day for 12 weeks in the Core Phase. Regardless of your response in the Core Phase, you may be eligible to enter the Extension Phase where all subjects will receive the study drug.

Subjects ages 6 years and below will receive a powder form of the study drug.