Summary

for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding.

Official Title

An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure

Details

Subjects will receive oral avatrombopag once daily for 5 days beginning on Day 1, followed by a wait period prior to the procedure, which will occur on Day 10 to 13. The Follow-up Period will include 2 visits; 7 days post-procedure and 30 days after last dose.

Keywords

Thrombocytopenia low platelet count ITP Avatrombopag 60 mg

Eligibility

You can join if…

Open to people ages 18 years and up

  • Men and women greater than or equal to 18 years of age;
  • A mean baseline platelet count between:
  • 50 × 109/L and <100 × 109/L for non-chronic liver disease participants

  • 50 × 109/L and <75 × 109/L for participants with chronic liver disease;

  • Participant is scheduled to undergo operations to critical sites (eg, eye surgery,neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), and, in the opinion of the Investigator, would otherwise require a platelet transfusion aiming for a platelet count of at least 100 × 109/L to prevent bleeding

You CAN'T join if...

  • Participant with a history of arterial or venous thrombosis;
  • Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of screening;
  • Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Screening Visit;
  • Use of anticoagulant or antiplatelet therapy;
  • Use of erythropoietin-stimulating agents;
  • Participant has a known medical history of genetic prothrombotic syndromes; or
  • Participant has abnormal hemoglobin levels or prothrombin time/international normalized ratio

Locations

  • Dova Site not yet accepting patients
    San Francisco California 94143 United States
  • Dova Site not yet accepting patients
    Reno Nevada 89503 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dova Pharmaceuticals
ID
NCT03326843
Phase
Phase 3
Study Type
Interventional
Last Updated
August 19, 2018