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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure

Conditions
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Thrombocytopenia

Intervention / Treatment
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* Drug: Avatrombopag 60 mg


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avatrombopag 60 mg<br>Open-label: oral avatrombopag | Drug: Avatrombopag 60 mg<br>* Oral avatrombopag administered once daily for 5 days prior to procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline to 10-13 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events | Incidence of treatment emergent adverse events | Up to 35 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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low platelet count, ITP