Thrombocytopenia
Conditions
Keywords
Chronic Liver Disease, Low Platelet Count
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.
Interventions
DRUGAvatrombopag
Avatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert.
Sponsors
Sobi, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in platelet count | Up to 8 days after the last dose of avatrombopag. |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed