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

NCT ID: NCT03554759

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-02

Study Completion Date

2019-01-31

Brief Summary

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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

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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.

Conditions

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Thrombocytopenia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Avatrombopag

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sobi, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Dova Site

Chandler, Arizona, United States

Site Status

Dova Site

Lancaster, California, United States

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Dova Study Site

Los Angeles, California, United States

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Dova Site

Palm Springs, California, United States

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Dova Study Site

Pasadena, California, United States

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Dova Study Site

San Clemente, California, United States

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Dova Study Site

San Diego, California, United States

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Dova Study Site

San Diego, California, United States

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Dova Study Site

Aurora, Colorado, United States

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Dova Study Site

Englewood, Colorado, United States

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Dova Study Site

Gainesville, Florida, United States

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Dova Study Site

Miami, Florida, United States

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Dova Study Site

Atlanta, Georgia, United States

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Dova Study Site

Topeka, Kansas, United States

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Dova Study Site

Louisville, Kentucky, United States

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Dova Study Site

Baltimore, Maryland, United States

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Dova Study Site

Boston, Massachusetts, United States

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Dova Study Site

Burlington, Massachusetts, United States

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Dova Study Site

Worcester, Massachusetts, United States

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Dova Study Site

Ann Arbor, Michigan, United States

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Dova Study Site

Detroit, Michigan, United States

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Dova Site

Jackson, Mississippi, United States

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Dova Study Site

New Brunswick, New Jersey, United States

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Dova Study Site

Manhasset, New York, United States

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Dova Study Site

New York, New York, United States

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Dova Study Site

The Bronx, New York, United States

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Dova Study Site

Durham, North Carolina, United States

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Dova Study Site

Cleveland, Ohio, United States

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Dova Study Site

Columbus, Ohio, United States

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Dova Study Site

Flourtown, Pennsylvania, United States

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Dova Site

Philadelphia, Pennsylvania, United States

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Dova Study Site

Pittsburgh, Pennsylvania, United States

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Dova Study Site

Johnson City, Tennessee, United States

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Dova Study Site

Memphis, Tennessee, United States

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Dova Study Site

Union City, Tennessee, United States

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Dova Study Site

Dallas, Texas, United States

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Dova Study Site

Houston, Texas, United States

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Dova Study Site

Charlottesville, Virginia, United States

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Dova Study Site

Richmond, Virginia, United States

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Dova Study SIte

Roanoke, Virginia, United States

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Dova Study Site

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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AVA-CLD-401

Identifier Type: -

Identifier Source: org_study_id

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