Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure

Phase 3

Terminated

• Conditions: Thrombocytopenia
• Interventions: Drug: Avatrombopag 60 mg

• Registration Number: NCT03326843
• Lead Sponsor: Sobi, Inc.

Brief Summary

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.

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.

Study Timeline

• Study First Submitted: 2017-10-27
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-10-31
• Study Start: 2018-03-26
• Status Verified: 2018-05
• Primary Completion: 2019-02-25
• Study Completion: 2019-02-25
• Results First Submitted: 2020-02-11
• Results First Submitted QC: 2020-04-03
• Last Update Submitted: 2020-04-03
• Results First Posted: 2020-04-15
• Last Update Posted: 2020-04-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avatrombopag 60 mg	Avatrombopag 60 mg	Open-label: oral avatrombopag

Primary Outcome Measures

Name	Time	Method
Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations	Baseline to 10-13 days	Proportion of subjects that achieve a platelet count \>100 x 10\^9 platelets/L on procedure day

Secondary Outcome Measures

Name	Time	Method
Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events	Up to 35 days	Incidence of treatment emergent adverse events

Trial Locations

Locations (1)

Dova Site; 🇺🇸 Milwaukee, Wisconsin, United States