Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
NCT ID: NCT03326843
Last Updated: 2020-04-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
4 participants
INTERVENTIONAL
2018-03-26
2019-02-25
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Avatrombopag 60 mg
Open-label: oral avatrombopag
Avatrombopag 60 mg
Oral avatrombopag administered once daily for 5 days prior to procedure.
Interventions
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Avatrombopag 60 mg
Oral avatrombopag administered once daily for 5 days prior to procedure.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Sobi, Inc.
INDUSTRY
Responsible Party
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Locations
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Dova Site
Little Rock, Arkansas, United States
Dova Site
Coronado, California, United States
Dova Site
Aurora, Colorado, United States
Dova Site
Jacksonville, Florida, United States
Dova Site
Jacksonville, Florida, United States
Dova Site
Miami, Florida, United States
Dova Site
Miami, Florida, United States
Dova Site
Pensacola, Florida, United States
Dova Site
Sarasota, Florida, United States
Dova Site
Tamarac, Florida, United States
Dova Site
Tampa, Florida, United States
Dova Site
New Orleans, Louisiana, United States
Dova Site
Baltimore, Maryland, United States
Dova Site
Boston, Massachusetts, United States
Dova Site
Detroit, Michigan, United States
Dova Site
Springfield, Missouri, United States
Dova Site
St Louis, Missouri, United States
Dova Site
Reno, Nevada, United States
Dova Site
Englewood, New Jersey, United States
Dova Site
Buffalo, New York, United States
Dova Site
Durham, North Carolina, United States
Dova Site
Winston-Salem, North Carolina, United States
Dova Site
Toledo, Ohio, United States
Dova Site
Bethlehem, Pennsylvania, United States
Dova Site
Austin, Texas, United States
Dova Site
Newport News, Virginia, United States
Dova Site
Milwaukee, Wisconsin, United States
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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AVA-PST-320
Identifier Type: -
Identifier Source: org_study_id
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