Study Stopped
Study was terminated early due to enrollment challenges
Avatrombopag for the Treatment of Thrombocytopenia in Adults With Chronic Liver Disease Undergoing a Procedure
An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure
1 other identifier
observational
50
1 country
41
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2018
Shorter than P25 for all trials
41 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 22, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedStudy Start
First participant enrolled
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2019
CompletedOctober 21, 2024
October 1, 2024
7 months
May 22, 2018
October 17, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in platelet count
Up to 8 days after the last dose of avatrombopag.
Secondary Outcomes (2)
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
Interventions
Avatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert.
Eligibility Criteria
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.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sobi, Inc.lead
Study Sites (41)
Dova Site
Chandler, Arizona, 85224, United States
Dova Site
Lancaster, California, 93534, United States
Dova Study Site
Los Angeles, California, 90048, United States
Dova Site
Palm Springs, California, 92262, United States
Dova Study Site
Pasadena, California, 91107, United States
Dova Study Site
San Clemente, California, 92673, United States
Dova Study Site
San Diego, California, 92114, United States
Dova Study Site
San Diego, California, 92121, United States
Dova Study Site
Aurora, Colorado, 80045, United States
Dova Study Site
Englewood, Colorado, 80113, United States
Dova Study Site
Gainesville, Florida, 32610, United States
Dova Study Site
Miami, Florida, 33136, United States
Dova Study Site
Atlanta, Georgia, 30309, United States
Dova Study Site
Topeka, Kansas, 66606, United States
Dova Study Site
Louisville, Kentucky, 40202, United States
Dova Study Site
Baltimore, Maryland, 21202, United States
Dova Study Site
Boston, Massachusetts, 02215, United States
Dova Study Site
Burlington, Massachusetts, 01805, United States
Dova Study Site
Worcester, Massachusetts, 01655, United States
Dova Study Site
Ann Arbor, Michigan, 48109, United States
Dova Study Site
Detroit, Michigan, 48239, United States
Dova Site
Jackson, Mississippi, 39216, United States
Dova Study Site
New Brunswick, New Jersey, 08901, United States
Dova Study Site
Manhasset, New York, 11030, United States
Dova Study Site
New York, New York, 10016, United States
Dova Study Site
The Bronx, New York, 10467, United States
Dova Study Site
Durham, North Carolina, 27710, United States
Dova Study Site
Cleveland, Ohio, 44016, United States
Dova Study Site
Columbus, Ohio, 43210, United States
Dova Study Site
Flourtown, Pennsylvania, 19031, United States
Dova Site
Philadelphia, Pennsylvania, 19141, United States
Dova Study Site
Pittsburgh, Pennsylvania, 15213, United States
Dova Study Site
Johnson City, Tennessee, 37604, United States
Dova Study Site
Memphis, Tennessee, 38104, United States
Dova Study Site
Union City, Tennessee, 38261, United States
Dova Study Site
Dallas, Texas, 75234, United States
Dova Study Site
Houston, Texas, 77030, United States
Dova Study Site
Charlottesville, Virginia, 22908, United States
Dova Study Site
Richmond, Virginia, 23226, United States
Dova Study SIte
Roanoke, Virginia, 24014, United States
Dova Study Site
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 22, 2018
First Posted
June 13, 2018
Study Start
July 2, 2018
Primary Completion
January 31, 2019
Study Completion
January 31, 2019
Last Updated
October 21, 2024
Record last verified: 2024-10