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NCT03554759 Clinical Trial

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

Thrombocytopenia Clinical Trial

Official title:
An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03554759
Other study ID # AVA-CLD-401
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date July 2, 2018
Est. completion date January 31, 2019

Study information
Verified date July 2018
Source Dova Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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 information / eligibility
Status Terminated
Enrollment 50
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Avatrombopag
Avatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert.

Locations
Country Name City State
United States Dova Study Site Ann Arbor Michigan
United States Dova Study Site Atlanta Georgia
United States Dova Study Site Aurora Colorado
United States Dova Study Site Baltimore Maryland
United States Dova Study Site Boston Massachusetts
United States Dova Study Site Bronx New York
United States Dova Study Site Burlington Massachusetts
United States Dova Site Chandler Arizona
United States Dova Study Site Charlottesville Virginia
United States Dova Study Site Cleveland Ohio
United States Dova Study Site Columbus Ohio
United States Dova Study Site Dallas Texas
United States Dova Study Site Detroit Michigan
United States Dova Study Site Durham North Carolina
United States Dova Study Site Englewood Colorado
United States Dova Study Site Flourtown Pennsylvania
United States Dova Study Site Gainesville Florida
United States Dova Study Site Houston Texas
United States Dova Site Jackson Mississippi
United States Dova Study Site Johnson City Tennessee
United States Dova Site Lancaster California
United States Dova Study Site Los Angeles California
United States Dova Study Site Louisville Kentucky
United States Dova Study Site Manhasset New York
United States Dova Study Site Memphis Tennessee
United States Dova Study Site Miami Florida
United States Dova Study Site Milwaukee Wisconsin
United States Dova Study Site New Brunswick New Jersey
United States Dova Study Site New York New York
United States Dova Site Palm Springs California
United States Dova Study Site Pasadena California
United States Dova Site Philadelphia Pennsylvania
United States Dova Study Site Pittsburgh Pennsylvania
United States Dova Study Site Richmond Virginia
United States Dova Study SIte Roanoke Virginia
United States Dova Study Site San Clemente California
United States Dova Study Site San Diego California
United States Dova Study Site San Diego California
United States Dova Study Site Topeka Kansas
United States Dova Study Site Union City Tennessee
United States Dova Study Site Worcester Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Dova Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in platelet count Up to 8 days after the last dose of avatrombopag.
Secondary 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
Secondary Occurrence of adverse events From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag
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