NCT03554759

Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure

An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 50 (actual)
• Sponsor: Sobi, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

Phase 4 observational cohort study to characterize the treatment patterns and effects of avatrombopag use in patients with thrombocytopenia associated with chronic liver disease who are either undergoing, or have already undergone, a procedure.

Detailed description

Data (e.g. type of procedure, platelet count, etc.) will be collected retrospectively or prospectively from patient visits occurring within approximately 7 calendar days prior to the first dose of avatrombopag, on Procedure Day, on Discharge Day, and from any clinic visit performed up to 30 days post-procedure. All treatment decisions and clinical assessments will be at the discretion of the treating physician per routine medical care and are not mandated by study design or protocol.

Conditions

• Thrombocytopenia

Interventions

Type	Name	Description
DRUG	Avatrombopag	Avatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert.

Timeline

• Start date: 2018-07-02
• Primary completion: 2019-01-31
• Completion: 2019-01-31
• First posted: 2018-06-13
• Last updated: 2024-10-21

Locations

41 sites across 1 country: United States

Regulatory

• FDA-regulated drug study