Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
Status: | Terminated |
---|---|
Conditions: | Hematology |
Therapuetic Areas: | Hematology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/10/2019 |
Start Date: | March 26, 2018 |
End Date: | February 25, 2019 |
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 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 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.
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.
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
We found this trial at
25
sites
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