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

April 3, 2020 updated by: Sobi, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Avatrombopag 60 mg
Open-label: oral avatrombopag
Drug: Avatrombopag 60 mg
Oral avatrombopag administered once daily for 5 days prior to procedure.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Baseline to 10-13 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Evaluate Safety of Avatrombopag: Incidence of Treatment Emergent Adverse Events
Time Frame: Up to 35 days
Incidence of treatment emergent adverse events
Up to 35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sobi, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 25, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 25, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 30, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 31, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 15, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 3, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • AVA-PST-320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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