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

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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

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.

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
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Buffalo, New York 14203
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Aurora, Colorado 80045
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Austin, Texas 78731
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Baltimore, Maryland 21202
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Bethlehem, Pennsylvania 18015
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Boston, Massachusetts 02215
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Coronado, California 92118
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Detroit, Michigan 48202
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Detroit, MI
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Durham, North Carolina 27710
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Durham, NC
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Englewood, New Jersey 07631
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Jacksonville, Florida 32209
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Little Rock, Arkansas 72205
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Miami, Florida 33135
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10437 West Innovation Drive
Milwaukee, Wisconsin 53226
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New Orleans, Louisiana 70112
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Newport News, Virginia 23602
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Pensacola, Florida 32503
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Reno, Nevada 89503
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Saint Louis, Missouri 63110
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Sarasota, Florida 34232
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Springfield, Missouri 65807
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Tamarac, Florida 33321
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Tampa, Florida 33615
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Toledo, Ohio 43606
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Winston-Salem, North Carolina 27157
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