Status:
TERMINATED
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
Lead Sponsor:
Sobi, Inc.
Conditions:
Thrombocytopenia
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 o...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 25 2019
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT03326843
Start Date
March 26 2018
End Date
February 25 2019
Last Update
April 15 2020
Active Locations (27)
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1
Dova Site
Little Rock, Arkansas, United States, 72205
2
Dova Site
Coronado, California, United States, 92118
3
Dova Site
Aurora, Colorado, United States, 80045
4
Dova Site
Jacksonville, Florida, United States, 32209