Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure

Sobi

Status and phase

Terminated

Phase 3

Conditions

Thrombocytopenia

Treatments

Drug: Avatrombopag 60 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT03326843

AVA-PST-320

Details and patient eligibility

About

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.

Full description

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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