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

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ClinicalTrials.gov Identifier: NCT03326843
Recruitment Status : Recruiting
First Posted : October 31, 2017
Last Update Posted : October 29, 2018
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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
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
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 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/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



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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


Contacts
Contact: Dova Clinical 919-338-7878 clinical@dova.com

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Sponsors and Collaborators
Dova Pharmaceuticals

Responsible Party: Dova Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03326843     History of Changes
Other Study ID Numbers: AVA-PST-320
First Posted: October 31, 2017    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: May 2018

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:
Thrombocytopenia
Blood Platelet Disorders
Hematologic Diseases