Clinical trial NCT03554759: Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure
Official title: An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Thrombocytopenia
Keywords: Chronic Liver Disease
Low Platelet Count
Lead sponsor: Sobi, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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

Primary outcomes:
measure: Change in platelet count
timeFrame: Up to 8 days after the last dose of avatrombopag.
Secondary outcomes:
measure: Proportion of patients who received a platelet transfusion
timeFrame: From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag
measure: Occurrence of adverse events
timeFrame: From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Dova Site
state: Arizona
city: Lancaster
country: United States
facility: Dova Site
state: California
city: Los Angeles
country: United States
facility: Dova Study Site
state: California
city: Palm Springs
country: United States
facility: Dova Site
state: California
city: Pasadena
country: United States
facility: Dova Study Site
state: California
city: San Clemente
country: United States
facility: Dova Study Site
state: California
city: San Diego
country: United States
facility: Dova Study Site
state: California
city: San Diego
country: United States
facility: Dova Study Site
state: California
city: Aurora
country: United States
facility: Dova Study Site
state: Colorado
city: Englewood
country: United States
facility: Dova Study Site
state: Colorado
city: Gainesville
country: United States
facility: Dova Study Site
state: Florida
city: Miami
country: United States
facility: Dova Study Site
state: Florida
city: Atlanta
country: United States
facility: Dova Study Site
state: Georgia
city: Topeka
country: United States
facility: Dova Study Site
state: Kansas
city: Louisville
country: United States
facility: Dova Study Site
state: Kentucky
city: Baltimore
country: United States
facility: Dova Study Site
state: Maryland
city: Boston
country: United States
facility: Dova Study Site
state: Massachusetts
city: Burlington
country: United States
facility: Dova Study Site
state: Massachusetts
city: Worcester
country: United States
facility: Dova Study Site
state: Massachusetts
city: Ann Arbor
country: United States
facility: Dova Study Site
state: Michigan
city: Detroit
country: United States
facility: Dova Study Site
state: Michigan
city: Jackson
country: United States
facility: Dova Site
state: Mississippi
city: New Brunswick
country: United States
facility: Dova Study Site
state: New Jersey
city: Bronx
country: United States
facility: Dova Study Site
state: New York
city: Manhasset
country: United States
facility: Dova Study Site
state: New York
city: New York
country: United States
facility: Dova Study Site
state: New York
city: Durham
country: United States
facility: Dova Study Site
state: North Carolina
city: Cleveland
country: United States
facility: Dova Study Site
state: Ohio
city: Columbus
country: United States
facility: Dova Study Site
state: Ohio
city: Flourtown
country: United States
facility: Dova Study Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Dova Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Dova Study Site
state: Pennsylvania
city: Johnson City
country: United States
facility: Dova Study Site
state: Tennessee
city: Memphis
country: United States
facility: Dova Study Site
state: Tennessee
city: Union City
country: United States
facility: Dova Study Site
state: Tennessee
city: Dallas
country: United States
facility: Dova Study Site
state: Texas
city: Houston
country: United States
facility: Dova Study Site
state: Texas
city: Charlottesville
country: United States
facility: Dova Study Site
state: Virginia
city: Richmond
country: United States
facility: Dova Study Site
state: Virginia
city: Roanoke
country: United States
facility: Dova Study SIte
state: Virginia
city: Milwaukee
country: United States
facility: Dova Study Site
state: Wisconsin
Study officials:
References: