Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
Purpose
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.
Condition
- Thrombocytopenia
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Avatrombopag 60 mg |
Open-label: oral avatrombopag |
|
Recruiting Locations
More Details
- NCT ID
- NCT03326843
- Status
- Terminated
- Sponsor
- Sobi, Inc.
Detailed 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.