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

Sobi

Status: Terminated

Conditions: Thrombocytopenia

Treatments: Drug: Avatrombopag

Study type: Observational

Funder types: Industry

Identifiers

NCT03554759

AVA-CLD-401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Patient has thrombocytopenia associated with chronic liver disease and is planned for or underwent treatment with avatrombopag prior to a procedure
• Patient provides written informed consent

Minimum Data for Retrospective Enrollment

• Platelet count from approximately 7 days prior to starting avatrombopag
• Platelet count on Procedure Day