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

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ClinicalTrials.gov Identifier: NCT03554759
Recruitment Status : Recruiting
First Posted : June 13, 2018
Last Update Posted : November 29, 2018
Sponsor:
Information provided by (Responsible Party):
Dova Pharmaceuticals

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.

Condition or disease Intervention/treatment
Thrombocytopenia Drug: Avatrombopag

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
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational Cohort Study of the Use of Avatrombopag in Patients With Thrombocytopenia Associated With Chronic Liver Disease Undergoing a Procedure
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases


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


Primary Outcome Measures :
  1. Change in platelet count [ Time Frame: Up to 8 days after the last dose of avatrombopag. ]

Secondary Outcome Measures :
  1. 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 ]
  2. Occurrence of adverse events [ Time Frame: From the first dose of avatrombopag to up to 30 days after the last dose of avatrombopag ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03554759


Contacts
Contact: Dova Clinical 919-338-7878 clinical@dova.com

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Sponsors and Collaborators
Dova Pharmaceuticals

Responsible Party: Dova Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03554759     History of Changes
Other Study ID Numbers: AVA-CLD-401
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: November 29, 2018
Last Verified: July 2018

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

Keywords provided by Dova Pharmaceuticals:
Chronic Liver Disease
Low Platelet Count

Additional relevant MeSH terms:
Liver Diseases
Thrombocytopenia
Digestive System Diseases
Blood Platelet Disorders
Hematologic Diseases