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

• ClinicalTrials.gov Identifier: NCT03554759
• Recruitment Status: Terminated
• First Posted: June 13, 2018
• Last Update Posted: March 8, 2019
• Sponsor: Sobi, Inc.
• Information provided by (Responsible Party): Sobi, Inc.

Tracking Information

• First Submitted Date: May 22, 2018
• First Posted Date: June 13, 2018
• Last Update Posted Date: March 8, 2019
• Actual Study Start Date: July 2, 2018
• Actual Primary Completion Date: January 31, 2019 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 31, 2018): Change in platelet count [ Time Frame: Up to 8 days after the last dose of avatrombopag. ]
• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 31, 2018)

• Proportion of patients who received a platelet transfusion [ Time Frame: From the first dose of avatrombopag to up to 15 days after the last dose of avatrombopag ]
• Occurrence of adverse events [ Time Frame: From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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
• 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.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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.
• Condition: Thrombocytopenia

Intervention

Drug: Avatrombopag

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

• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: March 6, 2019): 50
• Original Estimated Enrollment (submitted: May 31, 2018): 500
• Actual Study Completion Date: January 31, 2019
• Actual Primary Completion Date: January 31, 2019 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03554759
• Other Study ID Numbers: AVA-CLD-401
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Product Manufactured in and Exported from the U.S.: No

• IPD Sharing Statement: Not Provided
• Current Responsible Party: Sobi, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Sobi, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Sobi, Inc.
• Verification Date: July 2018