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



Status:Terminated
Conditions:Hematology
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:3/10/2019
Start Date:March 26, 2018
End Date:February 25, 2019

Use our guide to learn which trials are right for you!

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.

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.

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
We found this trial at
25
sites
Englewood, New Jersey 07631
?
mi
from
Englewood, NJ
Click here to add this to my saved trials
Aurora, Colorado 80045
?
mi
from
Aurora, CO
Click here to add this to my saved trials
Austin, Texas 78731
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21202
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bethlehem, Pennsylvania 18015
?
mi
from
Bethlehem, PA
Click here to add this to my saved trials
Boston, Massachusetts 02215
?
mi
from
Boston, MA
Click here to add this to my saved trials
Buffalo, New York 14203
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
Coronado, California 92118
?
mi
from
Coronado, CA
Click here to add this to my saved trials
Detroit, Michigan 48202
?
mi
from
Detroit, MI
Click here to add this to my saved trials
Durham, North Carolina 27710
?
mi
from
Durham, NC
Click here to add this to my saved trials
Jacksonville, Florida 32209
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Miami, Florida 33135
?
mi
from
Miami, FL
Click here to add this to my saved trials
10437 West Innovation Drive
Milwaukee, Wisconsin 53226
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
New Orleans, Louisiana 70112
?
mi
from
New Orleans, LA
Click here to add this to my saved trials
Newport News, Virginia 23602
?
mi
from
Newport News, VA
Click here to add this to my saved trials
Pensacola, Florida 32503
?
mi
from
Pensacola, FL
Click here to add this to my saved trials
Reno, Nevada 89503
?
mi
from
Reno, NV
Click here to add this to my saved trials
Saint Louis, Missouri 63110
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Sarasota, Florida 34232
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
Springfield, Missouri 65807
?
mi
from
Springfield, MO
Click here to add this to my saved trials
Tamarac, Florida 33321
?
mi
from
Tamarac, FL
Click here to add this to my saved trials
Tampa, Florida 33615
?
mi
from
Tampa, FL
Click here to add this to my saved trials
Toledo, Ohio 43606
?
mi
from
Toledo, OH
Click here to add this to my saved trials
Winston-Salem, North Carolina 27157
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials