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

Primary Purpose

Thrombocytopenia

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Avatrombopag 60 mg
Sponsored by
Sobi, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thrombocytopenia focused on measuring low platelet count, ITP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
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  • Dova Site
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  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site
  • Dova Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Avatrombopag 60 mg

Arm Description

Open-label: oral avatrombopag

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events
Incidence of treatment emergent adverse events

Full Information

First Posted
October 27, 2017
Last Updated
April 3, 2020
Sponsor
Sobi, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03326843
Brief Title
Avatrombopag for the Treatment of Thrombocytopenia in Adults Scheduled for a Surgical Procedure
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Study was terminated due to enrollment challenges.
Study Start Date
March 26, 2018 (Actual)
Primary Completion Date
February 25, 2019 (Actual)
Study Completion Date
February 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sobi, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thrombocytopenia
Keywords
low platelet count, ITP

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Avatrombopag 60 mg
Arm Type
Experimental
Arm Description
Open-label: oral avatrombopag
Intervention Type
Drug
Intervention Name(s)
Avatrombopag 60 mg
Intervention Description
Oral avatrombopag administered once daily for 5 days prior to procedure.
Primary Outcome Measure Information:
Title
Evaluate Efficacy of Avatrombopag in Increasing Platelet Counts in Subjects With Thrombocytopenia Scheduled for Operations
Description
Proportion of subjects that achieve a platelet count >100 x 10^9 platelets/L on procedure day
Time Frame
Baseline to 10-13 days
Secondary Outcome Measure Information:
Title
Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events
Description
Incidence of treatment emergent adverse events
Time Frame
Up to 35 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Dova Site
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Dova Site
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Dova Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Dova Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Dova Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
Dova Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Dova Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Dova Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32503
Country
United States
Facility Name
Dova Site
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34232
Country
United States
Facility Name
Dova Site
City
Tamarac
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Dova Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Dova Site
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Dova Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202
Country
United States
Facility Name
Dova Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Dova Site
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Dova Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dova Site
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Dova Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Dova Site
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Facility Name
Dova Site
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Dova Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Dova Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Dova Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Dova Site
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Dova Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78731
Country
United States
Facility Name
Dova Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Facility Name
Dova Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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