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

Stopped early · Phase 3

Conditions studied: Thrombocytopenia

In brief

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.

Key facts

Study ID

NCT03326843

Run by

Sobi, Inc.

People needed

4

Starts

2018-03-26

Expected to finish

2019-02-25

Last updated by the study team

2020-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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