Title
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure
Phase
Phase 3Lead Sponsor
Dova PharmaceuticalsStudy Type
InterventionalStatus
Terminated Results PostedIndication/Condition
ThrombocytopeniaIntervention/Treatment
Avatrombopag 60 mgStudy Participants
4Phase 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.
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.
Oral avatrombopag administered once daily for 5 days prior to procedure.
Inclusion Criteria: Men and women greater than or equal to 18 years of age; A mean baseline platelet count between: 50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants 50 × 10^9/L and <75 × 10^9/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), or, in the opinion of the Investigator, would otherwise require a pre-operative platelet transfusion to prevent bleeding Exclusion Criteria: Participant with a history of arterial or venous thrombosis within 6 months of baseline; Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of baseline; Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Baseline Visit; 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
| Event Type | Organ System | Event Term | Avatrombopag 60 mg |
|---|
Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day
Incidence of treatment emergent adverse events
