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Purpose

Phase 3b open-label, multicenter study to evaluate the safety and efficacy of avatrombopag in subjects with thrombocytopenia scheduled for operations to critical sites or operations with a high risk of bleeding.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Men and women greater than or equal to 18 years of age; - A mean baseline platelet count between: - 50 × 10^9/L and <100 × 10^9/L for non-chronic liver disease participants - 50 × 10^9/L and <75 × 10^9/L for participants with chronic liver disease; - Participant is scheduled to undergo operations to critical sites (eg, eye surgery, neurosurgery) or operations with a high risk of bleeding (eg, major abdominal surgery), or, in the opinion of the Investigator, would otherwise require a pre-operative platelet transfusion to prevent bleeding

Exclusion Criteria

  • Participant with a history of arterial or venous thrombosis within 6 months of baseline; - Participant with known portal vein blood flow velocity rate <10 cm/second or previous portal vein thrombosis within 6 months of baseline; - Participant plans to have a platelet transfusion or plans to receive blood products containing platelets within 7 days of the Baseline Visit; - Use of erythropoietin-stimulating agents; - Participant has a known medical history of genetic prothrombotic syndromes; or - Participant has abnormal hemoglobin levels or prothrombin time/international normalized ratio

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Avatrombopag 60 mg 		Open-label: oral avatrombopag
  • Drug: Avatrombopag 60 mg
    Oral avatrombopag administered once daily for 5 days prior to procedure.

Recruiting Locations

More Details

NCT ID
NCT03326843
Status
Terminated
Sponsor
Sobi, Inc.

Detailed Description

Subjects will receive oral avatrombopag once daily for 5 days beginning on Day 1, followed by a wait period prior to the procedure, which will occur on Day 10 to 13. The Follow-up Period will include 2 visits; 7 days post-procedure and 30 days after last dose.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.