NCT03326843

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Sobi, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Avatrombopag 60 mg	Oral avatrombopag administered once daily for 5 days prior to procedure.

Timeline

• Start date: 2018-03-26
• Primary completion: 2019-02-25
• Completion: 2019-02-25
• First posted: 2017-10-31
• Last updated: 2020-04-15
• Results posted: 2020-04-15

Locations

27 sites across 1 country: United States

Regulatory

• FDA-regulated drug study