Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03326843
Recruitment Status : Terminated (Study was terminated due to enrollment challenges.)
First Posted : October 31, 2017
Results First Posted : February 26, 2020
Last Update Posted : April 15, 2020
Sponsor:
Information provided by (Responsible Party):
Dova Pharmaceuticals

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
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

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.




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 platelets/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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03326843


Locations
Layout table for location information
United States, Arkansas
Dova Site
Little Rock, Arkansas, United States, 72205
United States, California
Dova Site
Coronado, California, United States, 92118
United States, Colorado
Dova Site
Aurora, Colorado, United States, 80045
United States, Florida
Dova Site
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
United States, Louisiana
Dova Site
New Orleans, Louisiana, United States, 70112
United States, Maryland
Dova Site
Baltimore, Maryland, United States, 21202
United States, Massachusetts
Dova Site
Boston, Massachusetts, United States, 02115
United States, Michigan
Dova Site
Detroit, Michigan, United States, 48202
United States, Missouri
Dova Site
Saint Louis, Missouri, United States, 63110
Dova Site
Springfield, Missouri, United States, 65807
United States, Nevada
Dova Site
Reno, Nevada, United States, 89503
United States, New Jersey
Dova Site
Englewood, New Jersey, United States, 07631
United States, New York
Dova Site
Buffalo, New York, United States, 14203
United States, North Carolina
Dova Site
Durham, North Carolina, United States, 27710
Dova Site
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Dova Site
Toledo, Ohio, United States, 43606
United States, Pennsylvania
Dova Site
Bethlehem, Pennsylvania, United States, 18015
United States, Texas
Dova Site
Austin, Texas, United States, 78731
United States, Virginia
Dova Site
Newport News, Virginia, United States, 23602
United States, Wisconsin
Dova Site
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Dova Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Dova Pharmaceuticals:
Study Protocol  [PDF] September 17, 2018
Statistical Analysis Plan  [PDF] January 22, 2019

Layout table for additonal information
Responsible Party: Dova Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03326843    
Other Study ID Numbers: AVA-PST-320
First Posted: October 31, 2017    Key Record Dates
Results First Posted: February 26, 2020
Last Update Posted: April 15, 2020
Last Verified: May 2018

Layout table for additional information
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:
Layout table for MeSH terms
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases