We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03554759
Recruitment Status : Terminated (Study was terminated early due to enrollment challenges)
First Posted : June 13, 2018
Last Update Posted : March 8, 2019
Sponsor:
Information provided by (Responsible Party):
Sobi, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 50 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
Actual Primary Completion Date : January 31, 2019
Actual Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Locations
Show Show 41 study locations
Sponsors and Collaborators
Sobi, Inc.
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Sobi, Inc.
ClinicalTrials.gov Identifier: NCT03554759    
Other Study ID Numbers: AVA-CLD-401
First Posted: June 13, 2018    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Sobi, Inc.:
Chronic Liver Disease
Low Platelet Count
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Thrombocytopenia
Digestive System Diseases
Blood Platelet Disorders
Hematologic Diseases