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

Thrombocytopenia Clinical Trial

Official title:

An Open-Label Study to Evaluate the Efficacy and Safety of Avatrombopag for the Treatment of Subjects With Thrombocytopenia Scheduled for a Surgical Procedure

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03326843
• Other study ID #: AVA-PST-320
• Status: Terminated
• Phase: Phase 3
• Start date: March 26, 2018
• Est. completion date: February 25, 2019

Study information

• Verified date: May 2018
• Source: Dova Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: February 25, 2019
• Est. primary completion date: February 25, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thrombocytopenia

Intervention

Drug:
• Avatrombopag 60 mg
Oral avatrombopag administered once daily for 5 days prior to procedure.

Locations

Country	Name	City	State
United States	Dova Site	Aurora	Colorado
United States	Dova Site	Austin	Texas
United States	Dova Site	Baltimore	Maryland
United States	Dova Site	Bethlehem	Pennsylvania
United States	Dova Site	Boston	Massachusetts
United States	Dova Site	Buffalo	New York
United States	Dova Site	Coronado	California
United States	Dova Site	Detroit	Michigan
United States	Dova Site	Durham	North Carolina
United States	Dova Site	Englewood	New Jersey
United States	Dova Site	Jacksonville	Florida
United States	Dova Site	Jacksonville	Florida
United States	Dova Site	Little Rock	Arkansas
United States	Dova Site	Miami	Florida
United States	Dova Site	Miami	Florida
United States	Dova Site	Milwaukee	Wisconsin
United States	Dova Site	New Orleans	Louisiana
United States	Dova Site	Newport News	Virginia
United States	Dova Site	Pensacola	Florida
United States	Dova Site	Reno	Nevada
United States	Dova Site	Saint Louis	Missouri
United States	Dova Site	Sarasota	Florida
United States	Dova Site	Springfield	Missouri
United States	Dova Site	Tamarac	Florida
United States	Dova Site	Tampa	Florida
United States	Dova Site	Toledo	Ohio
United States	Dova Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Dova Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations	Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day	Baseline to 10-13 days
Secondary	Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events	Incidence of treatment emergent adverse events	Up to 35 days