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Clinical Performance Evaluation of T-TAS 01 PL Chip

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03621020
Recruitment Status : Recruiting
First Posted : August 8, 2018
Last Update Posted : January 22, 2020
Sponsor:
Collaborator:
Fujimori Kogyo Co., Ltd.
Information provided by (Responsible Party):
Hikari Dx, Inc.

Brief Summary:
This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth.

Condition or disease Intervention/treatment
Platelet Dysfunction Von Willebrand Diseases Healthy Congenital Platelets Abnormality Diagnostic Test: T-TAS 01 PL Chip Diagnostic Test: PFA-100 Col/Epi and Col/ADP

Detailed Description:

This study will measure primary hemostatic ability using the T-TAS 01 System with PL chip, with a comparison to clinical truth. The study will be conducted at 3 locations in the United States and will enroll approximately 335 subjects. The following subject populations will be enrolled into the study (expected enrollment numbers indicated in parentheses):

  • Ostensibly healthy subjects without primary hemostasis abnormalities, e.g. a "healthy platelet" normal control population (N = 150)
  • Subjects taking 81+ mg daily aspirin (N = 81)
  • Subjects taking dual antiplatelet therapy (N = 51)
  • Subjects with von Willebrand disease (vWD; N = 47)
  • Subjects with Glanzmann's thrombasthenia (N = 5)

Subjects may be recruited either prospectively or based on their simultaneous participation in other studies involving blood collection, provided that the enrollment criteria. Blood samples will be collected after enrollment and subject participation will be complete after blood samples are collected and all necessary information is collected to complete the case report form (CRF). Blood sample testing with T-TAS 01 will occur locally at each investigational site. Blood sample testing for clinical truth assessment may be tested either locally or remotely, depending on the local availability of the various tests used for determining clinical truth.

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Study Type : Observational
Estimated Enrollment : 335 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Performance Evaluation of T-TAS 01 PL Chip
Actual Study Start Date : September 1, 2018
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Healthy controls
Subjects not taking medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.
Diagnostic Test: T-TAS 01 PL Chip
Flow chamber microchip system specific for measuring primary hemostatic ability

Diagnostic Test: PFA-100 Col/Epi and Col/ADP
System for measuring platelet dysfunction

Aspirin monotherapy
Subjects taking 81+ mg daily aspirin and no additional medications with antiplatelet effects, without evidence of vWD or history of congenital platelet abnormalities, without history of significant bleeding.
Diagnostic Test: T-TAS 01 PL Chip
Flow chamber microchip system specific for measuring primary hemostatic ability

Diagnostic Test: PFA-100 Col/Epi and Col/ADP
System for measuring platelet dysfunction

von Willebrand Disease
Subjects diagnosed with vWD (all types except Type 2N), not taking medications with antiplatelet effects, and history of clinically significant bleeding.
Diagnostic Test: T-TAS 01 PL Chip
Flow chamber microchip system specific for measuring primary hemostatic ability

Diagnostic Test: PFA-100 Col/Epi and Col/ADP
System for measuring platelet dysfunction

Glanzmann's Thrombasthenia
Subjects diagnosed with Glanzmann's Thrombasthenia, not taking medications with antiplatelet effects, and history of clinically significant bleeding.
Diagnostic Test: T-TAS 01 PL Chip
Flow chamber microchip system specific for measuring primary hemostatic ability

Diagnostic Test: PFA-100 Col/Epi and Col/ADP
System for measuring platelet dysfunction

Dual antiplatelet therapy (DAPT)
Subjects taking 81 mg daily aspirin and either 75 mg daily clopidogrel, 10 mg daily prasugrel, or 180 mg daily ticagrelor
Diagnostic Test: T-TAS 01 PL Chip
Flow chamber microchip system specific for measuring primary hemostatic ability




Primary Outcome Measures :
  1. Sensitivity and specificity for detecting defects in primary hemostasis [ Time Frame: Baseline ]
    Sensitivity and specificity of the T-TAS 01 PL chip assay against clinical truth



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.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ostensibly healthy subjects without primary hemostasis abnormalities, e.g. a "healthy platelet" normal control population Subjects taking 81+ mg daily aspirin Subjects taking dual antiplatelet therapy Subjects with von Willebrand disease (vWD) Subjects with Glanzmann's thrombasthenia
Criteria

Normal Controls:

Inclusion Criteria

  • Males and females age 21 years or older.
  • Able and willing to provide written informed consent. Exclusion Criteria
  • Abnormal results from assays used to establish clinical truth (retrospective exclusion).
  • Hospitalization or doctor's visits within prior 30 days, except for routine checkup/physical examination.
  • Use of antiplatelet therapy within the past 14 days, e.g. aspirin, clopidogrel, prasugrel, ticagrelor, cilostazol.
  • Use of anticoagulant drugs within the past 14 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
  • Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, rofecoxib, etc. within the past 14 days.
  • History of anemia.
  • Known thrombocytopenia (platelet count < 100,000/μL).
  • Significant renal dysfunction or dialysis.
  • History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann's thrombasthenia or Bernard-Soulier syndrome.
  • History of hemophilia or bleeding disorders.
  • History of bleeding, with Bleeding Score ≥ 5 (Tosetto J Thromb Haemost 2006). See Appendix A. Scores will be assigned based on health history according to the following categories:

    • Epistaxis
    • Cutaneous bleeding
    • Bleeding from minor wounds
    • Bleeding from oral cavity
    • Gastrointestinal bleeding
    • Bleeding from tooth extraction
    • Surgical bleeding
    • Menorrhagia
    • Post-partum hemorrhage
    • Muscle hematoma
    • Hemarthrosis
    • Central nervous system bleeding
  • Females who are in the last trimester of pregnancy, or are breastfeeding.
  • Known active gastrointestinal disease including peptic ulcers, gastro-esophageal reflux disease (GERD), and hyperacidity.
  • Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
  • Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.

Antiplatelet Therapy Subjects:

Inclusion Criteria

  • Males and females age 21 years or older.
  • Continuous daily ingestion of one of the following antiplatelet therapy regimens:

    • 81 mg or higher aspirin
    • 81 mg or higher aspirin plus 75 mg daily clopidogrel
    • 81 mg or higher aspirin plus 10 mg daily prasugrel
    • 81 mg aspirin plus 180 mg daily ticagrelor
  • Able and willing to provide written informed consent. Exclusion Criteria
  • Use of antiplatelet therapy besides aspirin (e.g. clopidogrel, prasugrel, ticagrelor, cilostazol, abciximab, eptifibatide) within the past 14 days.
  • Use of anticoagulant drugs within the past 14 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
  • Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, rofecoxib, etc. within the past 14 days.
  • Significant renal dysfunction or dialysis.
  • Known thrombocytopenia (platelet count < 100,000/μL).
  • History of platelet disorders e.g. von Willebrand factor deficiency, Glanzmann thrombasthenia or Bernard-Soulier syndrome.
  • History of hemophilia or bleeding disorders.
  • Females who are in the last trimester of pregnancy, or are breastfeeding.
  • Known active gastrointestinal disease including peptic ulcers, gastro-esophageal reflux disease (GERD), and hyperacidity.
  • Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
  • Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.

vWD Subjects: Inclusion Criteria

  • Males and females age 21 years or older.
  • Prior diagnosis of von Willebrand disease type 1, 2A, 2B, 2M, or 3
  • History of bleeding, with Bleeding Score ≥ 5, which is 99% specific for vWD (Tosetto J Thromb Haemost 2006). See Appendix A. Scores will be assigned based on health history according to the following categories:

    • Epistaxis
    • Cutaneous bleeding
    • Bleeding from minor wounds
    • Bleeding from oral cavity
    • Gastrointestinal bleeding
    • Bleeding from tooth extraction
    • Surgical bleeding
    • Menorrhagia
    • Post-partum hemorrhage
    • Muscle hematoma
    • Hemarthrosis
    • Central nervous system bleeding
  • Able and willing to provide written informed consent. Exclusion Criteria
  • Prior diagnosis of von Willebrand disease type 2N
  • Receiving desmopressin or vWF replacement therapy within the past 2 weeks.
  • Use of antiplatelet therapy within the past 14 days.
  • Use of anticoagulant drugs within the past 14 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
  • Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, rofecoxib, etc. within the past 14 days.
  • Significant renal dysfunction or dialysis.
  • Known thrombocytopenia (platelet count < 100,000/μL).
  • Females who are in the last trimester of pregnancy, or are breastfeeding.
  • Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
  • Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.

Glanzmann's Thrombasthenia Subjects:

Inclusion Criteria

  • Males and females age 21 years or older.
  • Prior diagnosis of Glanzmann's thrombasthenia
  • History of bleeding.
  • Able and willing to provide written informed consent. Exclusion Criteria
  • Use of antiplatelet therapy within the past 14 days.
  • Use of anticoagulant drugs within the past 14 days, e.g. heparin, bivalirudin, warfarin, rivaroxaban, and apixaban.
  • Use of certain nonsteroidal anti-inflammatory drugs (NSAIDs) such as celecoxib, rofecoxib, etc. within the past 14 days.
  • Significant renal dysfunction or dialysis.
  • Known thrombocytopenia (platelet count < 100,000/μL).
  • Females who are in the last trimester of pregnancy, or are breastfeeding.
  • Currently participating in a study involving an investigational drug or compound known to affect coagulation or hemostasis.
  • Subjects with significant past medical history as determined by the Investigator that would pose safety concerns or interfere with the study goals.

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): NCT03621020


Contacts
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Contact: Jeffrey Dahlen, Ph.D. 619-742-0203 jeff@hikaridx.com

Locations
Layout table for location information
United States, California
San Francisco General Hospital Recruiting
San Francisco, California, United States, 94112
Contact: Jeffrey Dahlen, Ph.D.         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Jeffrey Dahlen, Ph.D.         
United States, Maryland
Sinai Hospital of Baltimore Active, not recruiting
Baltimore, Maryland, United States, 21215
Inova Cardiology Baltimore Completed
Lutherville, Maryland, United States, 21093
United States, Virginia
Inova Heart and Vascular Institute Completed
Falls Church, Virginia, United States, 22042
France
Centre Hospitalier Universitaire de Bordeaux Active, not recruiting
Bordeaux, CA, France, 92131
Sponsors and Collaborators
Hikari Dx, Inc.
Fujimori Kogyo Co., Ltd.
Investigators
Layout table for investigator information
Study Director: Jeffrey Dahlen, Ph.D. Hikari Dx, Inc.

Layout table for additonal information
Responsible Party: Hikari Dx, Inc.
ClinicalTrials.gov Identifier: NCT03621020    
Other Study ID Numbers: TQPL-RD-121-1
First Posted: August 8, 2018    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Von Willebrand Diseases
Blood Platelet Disorders
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics