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

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

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.

Study Overview

• Status: Terminated
• Conditions: Thrombocytopenia
• Intervention / Treatment: Drug: Avatrombopag 60 mg

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 Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Dova Site
  • California
    • Coronado, California, United States, 92118
      • Dova Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Dova Site
  • Florida
    • Jacksonville, Florida, United States, 32209
      • Dova Site
    • Jacksonville, Florida, United States, 32224
      • Dova Site
    • Miami, Florida, United States, 33135
      • Dova Site
    • Miami, Florida, United States, 33136
      • Dova Site
    • Pensacola, Florida, United States, 32503
      • Dova Site
    • Sarasota, Florida, United States, 34232
      • Dova Site
    • Tamarac, Florida, United States, 33321
      • Dova Site
    • Tampa, Florida, United States, 33615
      • Dova Site
  • Louisiana
    • New Orleans, Louisiana, United States, 70112
      • Dova Site
  • Maryland
    • Baltimore, Maryland, United States, 21202
      • Dova Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dova Site
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Dova Site
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Dova Site
    • Springfield, Missouri, United States, 65807
      • Dova Site
  • Nevada
    • Reno, Nevada, United States, 89503
      • Dova Site
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Dova Site
  • New York
    • Buffalo, New York, United States, 14203
      • Dova Site
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Dova Site
    • Winston-Salem, North Carolina, United States, 27157
      • Dova Site
  • Ohio
    • Toledo, Ohio, United States, 43606
      • Dova Site
  • Pennsylvania
    • Bethlehem, Pennsylvania, United States, 18015
      • Dova Site
  • Texas
    • Austin, Texas, United States, 78731
      • Dova Site
  • Virginia
    • Newport News, Virginia, United States, 23602
      • Dova Site
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Dova Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events	Incidence of treatment emergent adverse events	Up to 35 days

Collaborators and Investigators

• Sponsor: Sobi, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 26, 2018
• Primary Completion (ACTUAL): February 25, 2019
• Study Completion (ACTUAL): February 25, 2019

Study Registration Dates

• First Submitted: October 27, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (ACTUAL): October 31, 2017

Study Record Updates

• Last Update Posted (ACTUAL): April 15, 2020
• Last Update Submitted That Met QC Criteria: April 3, 2020
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: ITP; low platelet count
• Additional Relevant MeSH Terms: Hematologic Diseases; Blood Platelet Disorders; Thrombocytopenia
• Other Study ID Numbers: AVA-PST-320

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No