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.
Brief Title
Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing 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.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Thrombocytopenia
Eligibility 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
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Chronic Liver Disease
Low Platelet Count
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT03554759
Org Class
Industry
Org Full Name
Sobi, Inc.
Org Study Id
AVA-CLD-401
Overall Status
Terminated
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure
Primary Outcomes
Outcome Measure
Change in platelet count
Outcome Time Frame
Up to 8 days after the last dose of avatrombopag.
Secondary Outcomes
Outcome Time Frame
From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag
Outcome Measure
Proportion of patients who received a platelet transfusion
Outcome Time Frame
From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag
Outcome Measure
Occurrence of adverse events
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Study Population
Patients ≥18 years of age who have thrombocytopenia associated with chronic liver disease and are planned for or underwent treatment with avatrombopag prior to a procedure.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Samuel Sigal
Investigator Email
ssigal@montefiore.org
Investigator Phone
718-920-6240