Study Stopped
Study was terminated due to enrollment challenges.
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
1 other identifier
interventional
4
1 country
27
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Mar 2018
Shorter than P25 for phase_3
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 27, 2017
CompletedFirst Posted
Study publicly available on registry
October 31, 2017
CompletedStudy Start
First participant enrolled
March 26, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 25, 2019
CompletedResults Posted
Study results publicly available
April 15, 2020
CompletedApril 15, 2020
May 1, 2018
11 months
October 27, 2017
February 11, 2020
April 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events
Up to 35 days
Study Arms (1)
Avatrombopag 60 mg
EXPERIMENTALOpen-label: oral avatrombopag
Interventions
Oral avatrombopag administered once daily for 5 days prior to procedure.
Eligibility Criteria
You may qualify if:
- Men and women greater than or equal to 18 years of age;
- A mean baseline platelet count between:
- × 10\^9/L and \<100 × 10\^9/L for non-chronic liver disease participants
- × 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sobi, Inc.lead
Study Sites (27)
Dova Site
Little Rock, Arkansas, 72205, United States
Dova Site
Coronado, California, 92118, United States
Dova Site
Aurora, Colorado, 80045, United States
Dova Site
Jacksonville, Florida, 32209, United States
Dova Site
Jacksonville, Florida, 32224, United States
Dova Site
Miami, Florida, 33135, United States
Dova Site
Miami, Florida, 33136, United States
Dova Site
Pensacola, Florida, 32503, United States
Dova Site
Sarasota, Florida, 34232, United States
Dova Site
Tamarac, Florida, 33321, United States
Dova Site
Tampa, Florida, 33615, United States
Dova Site
New Orleans, Louisiana, 70112, United States
Dova Site
Baltimore, Maryland, 21202, United States
Dova Site
Boston, Massachusetts, 02115, United States
Dova Site
Detroit, Michigan, 48202, United States
Dova Site
Springfield, Missouri, 65807, United States
Dova Site
St Louis, Missouri, 63110, United States
Dova Site
Reno, Nevada, 89503, United States
Dova Site
Englewood, New Jersey, 07631, United States
Dova Site
Buffalo, New York, 14203, United States
Dova Site
Durham, North Carolina, 27710, United States
Dova Site
Winston-Salem, North Carolina, 27157, United States
Dova Site
Toledo, Ohio, 43606, United States
Dova Site
Bethlehem, Pennsylvania, 18015, United States
Dova Site
Austin, Texas, 78731, United States
Dova Site
Newport News, Virginia, 23602, United States
Dova Site
Milwaukee, Wisconsin, 53226, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Associate Director, Clinical Operations
- Organization
- Dova Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 27, 2017
First Posted
October 31, 2017
Study Start
March 26, 2018
Primary Completion
February 25, 2019
Study Completion
February 25, 2019
Last Updated
April 15, 2020
Results First Posted
April 15, 2020
Record last verified: 2018-05