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

• Sponsor: Dova Pharmaceuticals
• Information provided by (Responsible Party): Dova Pharmaceuticals

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Thrombocytopenia	Drug: Avatrombopag 60 mg	Phase 3

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 4 participants
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 26, 2018
• Actual Primary Completion Date: February 25, 2019
• Actual Study Completion Date: February 25, 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: Avatrombopag 60 mg; Open-label: oral avatrombopag	Drug: Avatrombopag 60 mg; Oral avatrombopag administered once daily for 5 days prior to procedure.

Outcome Measures

Primary Outcome Measures :

1. Evaluate efficacy of avatrombopag in increasing platelet counts in subjects with thrombocytopenia scheduled for operations [ Time Frame: Baseline to 10-13 days ]
   Proportion of subjects that achieve a platelet count >100 x 10^9/L on procedure day

Secondary Outcome Measures :

1. Evaluate Safety of avatrombopag: Incidence of treatment emergent adverse events [ Time Frame: Up to 35 days ]
   Incidence of treatment emergent adverse events

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

  Show 27 Study Locations

Sponsors and Collaborators

Dova Pharmaceuticals

More Information

• Responsible Party: Dova Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT03326843 History of Changes
• Other Study ID Numbers: AVA-PST-320
• First Posted: October 31, 2017
• Last Update Posted: March 8, 2019
• Last Verified: May 2018

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dova Pharmaceuticals:

low platelet count; ITP

Additional relevant MeSH terms:

Thrombocytopenia; Blood Platelet Disorders; Hematologic Diseases