Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure
- Conditions
- Thrombocytopenia
- Registration Number
- NCT03554759
- Lead Sponsor
- Sobi, Inc.
- Brief 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 50
- 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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in platelet count Up to 8 days after the last dose of avatrombopag.
- Secondary Outcome Measures
Name Time Method Proportion of patients who received a platelet transfusion From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag Occurrence of adverse events From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag
Trial Locations
- Locations (3)
Dova Site
🇺🇸Philadelphia, Pennsylvania, United States
Dova Study Site
🇺🇸Milwaukee, Wisconsin, United States
Dova Study SIte
🇺🇸Roanoke, Virginia, United States
Dova Site🇺🇸Philadelphia, Pennsylvania, United States