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 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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
Oral avatrombopag administered once daily for 5 days prior to procedure.
Dova Site
Little Rock, Arkansas, United States
Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations
Proportion of subjects that achieve a platelet count \>100 x 10\^9 platelets/L on procedure day
Time frame: Baseline to 10-13 days
Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events
Incidence of treatment emergent adverse events
Time frame: Up to 35 days
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Dova Site
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...and 17 more locations