Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy

April 18, 2020 updated by: Asahi Kasei Pharma America Corporation

A Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Assess the Safety and Efficacy of ART-123 in Subjects With Severe Sepsis and Coagulopathy.

The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.

Study Overview

Status

Status

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

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

Study is to evaluate if ART-123 given to patients who have severe sepsis complicated by at least one organ dysfunction and coagulopathy can decrease mortality.

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.
816

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

  • Argentina
      • Cordoba, Argentina, X5004BAL
        • Hospital Italiano de Córdoba
  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia
        • Prince of Wales Hospital
    • Queensland
      • Herston, Queensland, Australia
        • Royal Brisbane and Women's Hospital
      • Woolloongabba, Queensland, Australia
        • Princess Alexandra Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Bendigo, Victoria, Australia
        • Bendigo Hospital
      • Clayton, Victoria, Australia
        • Monash Medical Centre
      • Dandenong, Victoria, Australia, 3175
        • Dandenong Hospital Monash Health
      • Footscray, Victoria, Australia
        • Western Hospital
      • Heidelberg, Victoria, Australia
        • Austin Health
      • Melbourne, Victoria, Australia, 3021
        • Sunshine Hospital
  • Belgium
      • Antwerpen, Belgium
        • UZ Antwerpen
      • Arlon, Belgium
        • Cliniques Du Sud-Luxerbourg (CSL), Hospital Saint Joseph
      • Brussels, Belgium
        • Hopital Erasme
      • Brussels, Belgium
        • CHU Brugmann
      • Brussels, Belgium
        • UZ Brussel
      • Brussels, Belgium
        • Hôpitaux IRIS Sud
      • Brussels, Belgium
        • UCL St. Luc
      • Dinant, Belgium
        • Centre Hospitalier de Dinant
      • Gent, Belgium
        • UZ Gent
      • Ottignies, Belgium
        • Clinique Saint-PIerre
      • Yvoir, Belgium
        • UCL Mont-Godinne
  • Brazil
      • Brasil, Brazil, 95010-005
        • Hospital Pompeia
    • MG
      • Belo Horizonte, MG, Brazil
        • Santa Casa de Misericordia de Belo Horizonte
    • SP
      • Sao Jose do Rio Preto, SP, Brazil
        • Fundação Faculdade Regional de Medicina São José do Rio Preto
  • Bulgaria
      • Plovdiv, Bulgaria
        • Anesthesiology and Intensive Care Clinic, University Multiprofile Hospital For Active Treatment "Sveti Georgi", Plovdiv
      • Sofia, Bulgaria
        • Department of Anesthesiology and Intensive Care Multiprofile Hospital For Active Treatment "Tokuda Hospital Sofia", Sofia
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
        • 2 of 2
      • Calgary, Alberta, Canada, T2V 1PA
      • Calgary, Alberta, Canada, T3M 1M4
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • 2 of 2
      • Victoria, British Columbia, Canada, V8R-1J8
        • 1 of 2
      • Victoria, British Columbia, Canada, V8R1J8
    • Manitoba
      • Winnipeg, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • London, Ontario, Canada, N6A5W9
      • Ottawa, Ontario, Canada, KIH 8L6
        • 1 of 2
      • Ottawa, Ontario, Canada, KIH 8L6
        • 2 of 2
      • Windsor, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • Croatia
      • Zagreb, Croatia
        • Clinical Hospital Center Zagreb, Medical ICU
      • Zagreb, Croatia
        • Clinical Hospital Dubrava, Department of Anesthesiology and resuscitation
      • Zagreb, Croatia
        • University Hospital Center Zagreb, Department of Anesthesiology, Reanimatology and Intensive Care Medicine
  • Czechia
      • Brno, Czechia
        • University Hospital Brno, Department of Infectious Diseases
      • Hradec Kralove, Czechia
        • University Hospital Hradec Kralove, Department of Anaesthesiology, Resuscitation and Intensive Care
      • Prague 10, Czechia
        • University Hospital Kralovske Vinohrady, Department of Anesthesiology and Resuscitation
      • Prague 2, Czechia
        • General University Hospital in Prague, Department of Anaesthesiology, Resuscitation and Intensive Medicine
      • Usti nad Labem, Czechia
        • Masaryk´s Hospital Ustni nad Labem, o.z., Department of Infectious Diseases
  • Finland
      • Helsinki, Finland
        • Helsingin Yliopistollinen Keskussairaala (HYKS) (Helsinki University Central Hospital (HUCH))
      • Jyväskylä, Finland
        • Keski-Suomen Keskussairaala (Central Finland Central Hospital)
      • Kuopio, Finland
        • Kuopion Yliopistollinen Sairaala (KYS) (Kuopio University Hospital)
      • Tampere, Finland
        • Tampereen Yliopistollinen Sairaala (Tampere University Hospital) (TAYS) - Keskussairaala (Central Hospital)
  • France
      • Angers Cedex 9, France
        • CHU D'Anger
      • Dijon, France, 21000
        • CHU de Dijon, Hopital Bocage Central
      • Grenoble cedex 09, France
        • CH-Hôpital Albert Michallon
      • La Roche-Sur-Yon cedex 9, France
        • Centre Hospitalier Départemental de Vendée-Les Oudairies
      • Lille, France, 59037
        • CHRU Lille-Pole Reanimation
      • Limoges cedex, France
        • CHU Limoges
      • Nîmes Cedex 9, France
        • Centre Hospitalier Universitaire Nîmes
      • Paris, France
        • Hôpital Cochin
      • Paris, France, 75013
        • La Pitié Salpétrière, Paris
      • Pessac, France, 33600
        • University hospital of Bordeaux
      • Pierre-Bénite cedex, France
        • CH Lyon sud
      • Strasbourg, France, 67000
        • Nouvel Hospital Civil
      • Toulon, France
        • Hôpital Sainte Musse
      • Tours, France
        • CHU Tours, Hopital Bretonneau
    • Cedex 3
      • Nice, Cedex 3, France, 23079
        • Archet 1 University Hospital of Nice
    • Nantes Cedex 01
      • Nantes, Nantes Cedex 01, France, 44093
        • Service de reanimation médicale. CHU Hotel Dieu
  • Germany
      • Aachen, Germany, 54074
        • Universitatsklinikum der RWTH Aachen
      • Erfurt, Germany
        • Helios Klinikum Erfurt
      • Frankfurt am Main, Germany
        • Klinikum der Johann-Wolfgang Goethe-Universitat
  • Hungary
      • Budapest, Hungary, 1115
        • Szent Imre Hospital, Anesthesiology and Intensive Care Unit
  • India
      • Bangalore, India, 560099
        • Mazumdar Shaw Medical Centre (Unit of Narayana Health)
      • Belgaum, India, 590010
        • KLES Dr. Prabhakar Kore Hospital & Medical Research Centre
      • Mysore, India, 570004
        • JSS Hospital
      • Nagpur, India, 440010
        • Care hospital
      • Pune, India, 411013
        • Noble Hospital
    • Delhi
      • New Delhi, Delhi, India
        • Maulana Azad Medical College and Associated L N Hospital
    • Gujarat
      • Ahmedabad, Gujarat, India
        • Shalby
      • Ahmedabad,, Gujarat, India, 380015
        • Shalby Hospital
    • Haryana
      • Gurgaon, Haryana, India, 122001
        • Artemis Hospital
    • Maharashtra
      • Pune, Maharashtra, India, 411013
        • Noble Hospital
      • Pune, Maharashtra, India, 411011
        • Ruby Hall Clinic
      • Pune, Maharashtra, India
        • King Edward Memorial Hospital & Research Centre
    • Odisha
      • Bhubaneswar, Odisha, India
        • Hi-tech Medical College & Hospital
    • Pune, Maharashtra
      • Pune, Pune, Maharashtra, India, 411043
        • Bharati Vidyapeeth Deemed University Medical College Bharti Hospital and Research Centre
    • Telangana State
      • Hyderabad, Telangana State, India, 500018
        • St. Theresa Hospital
  • Israel
      • Ashkelon, Israel
        • Barzilai Medical Center
      • Haifa, Israel
        • Rambam Medical Center
      • Haifa, Israel
        • The Lady Davis Carmel Medical Center
      • Jerusalem, Israel
        • Shaare Zedek Medical Center
      • Petach Tikva, Israel
        • Rabin Medical Center
      • Rehovot, Israel
        • Kaplan Medical Center
  • Korea, Republic of
      • Seongdu, Korea, Republic of
        • Korea University Anam Hospital
      • Seoul, Korea, Republic of
        • Seoul National University Hospital
      • Seoul, Korea, Republic of
        • Asan Medical Center
      • Seoul, Korea, Republic of
        • Samsung Medical Center [Pulmonology]
  • Netherlands
      • 's-Hertogenbosch, Netherlands
        • Jeroen Bosch Ziekenhuis
      • Amsterdam, Netherlands
        • VUMC
      • Ede, Netherlands
        • Ziekenhuis Gelderse Vallei
      • Enschede, Netherlands
        • Medisch Spectrum Twente
      • Groningen, Netherlands
        • University Medical Center Groningen
      • Leeuwarden, Netherlands
        • Medisch Centrum Leeuwarden
      • Nijmegen, Netherlands
        • UMC St. Radboud
      • Rotterdam, Netherlands
        • Ikazia Ziekenhuis
  • New Zealand
      • Auckland, New Zealand
        • Auckland District Health Board
      • Christchurch, New Zealand
        • Christchurch Hospital
      • Hastings, New Zealand
        • Hawkes Bay Regional Hospital Intensive Care Unit Omahu Road
      • Newtown, New Zealand, 6021
        • Wellington District Health Board
  • Peru
    • Lima Province
      • Lima, Lima Province, Peru
        • Hospital Nacional Almenara Yrigoyen - EsSALUD
      • Lima, Lima Province, Peru
        • Hospital Nacional FAP
  • Russian Federation
      • Arkhangelsk, Russian Federation
        • Arkhangelsk Regional Clinical Hospital
      • Arkhangelsk, Russian Federation
        • Volosevich City Clinical Hospital #1
      • Kemerovo, Russian Federation, 650000
        • City Clinical Hospital #3 n.a. M.A. Pogorbunskiy
      • Krasnodar, Russian Federation
        • Kuban State Medical University (Site Facility: Krasnodar Regional Clinical Hospital #2)
      • Krasnoyarsk, Russian Federation, 660022
        • Krasnoyarsk Regional Clinocal Hospital
      • Moscow, Russian Federation
        • Vishnevsky Institute of Surgery
      • Saint Petersburg, Russian Federation, 194354
        • St George City Hospital
      • Saint Petersburg, Russian Federation
        • City hospital #40
      • Sochi, Russian Federation, 354057
        • City Hospital #4
      • St. Petersburg, Russian Federation
        • Aleksandrovskaya City Hospital
      • St. Petersburg, Russian Federation
        • Mariinskaya City Hospital
      • St. Petersburg, Russian Federation
        • Mechnikov North-Western State Medical University n.a. I.I. Mechnikov
  • Serbia
      • Nis, Serbia
        • Clinic for Infectious Diseases, Clinical Center Nis
  • Spain
      • A Coruña, Spain
        • Complexo Hospitalario Universitario A Coruña
      • Barcelona, Spain
        • Hospital Universitario Mutua Terrassa Intensive Care
      • Barcelona, Spain
        • Servicio de Medicina Intensiva Hospital Universitario Valle de Hebron
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Sabadell, Spain
        • Hospital de Sabadell
      • Tarragona, Spain
        • Hospital Universitari de Tarragona Joan XXIII
  • Taiwan
      • Taichung, Taiwan
        • Taichung Veterans General Hospital [Pulmonology]
      • Taipei, Taiwan
        • National Taiwan University Hospital
    • Tainan
      • Yongkang, Tainan, Taiwan
        • Chi Mei Medical Center Yong Kang
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Birmingham Heartlands Hospital
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • Liverpool, United Kingdom
        • Royal Liverpool University Hospital
      • Manchester, United Kingdom
        • Manchester Royal Infirmary
      • Plymouth, United Kingdom
        • Derriford Hospital
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
    • Arizona
      • Phoenix, Arizona, United States, 85008
    • Georgia
      • Atlanta, Georgia, United States, 30342
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Kentucky
      • Hazard, Kentucky, United States, 41701
      • Louisville, Kentucky, United States, 40202
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Receiving Hospital
      • Detroit, Michigan, United States, 48235
        • Sinai-Grace Hospital
      • Detroit, Michigan, United States, 48201
        • Harper Hospital - Wayne State University School of Medicine
    • Mississippi
      • Jackson, Mississippi, United States, 39216
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University in St. Louis
    • Montana
      • Butte, Montana, United States, 59701
    • New Jersey
      • Englewood, New Jersey, United States, 07631
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
    • North Carolina
      • Durham, North Carolina, United States, 27710
    • Ohio
      • Columbus, Ohio, United States, 43215
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
    • Texas
      • Houston, Texas, United States, 77030
        • 2 of 2
    • Utah
      • Murray, Utah, United States, 84107

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

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subject must be receiving treatment in an ICU, or in an acute care setting (e.g., ER, RR)
  • Clinical objective evidence of bacterial infection and a known site of infection.
  • Cardiovascular dysfunction or Respiratory Failure due to sepsis.
  • Coagulopathy characterized by an INR >1.40 without other known causes.

Exclusion Criteria:

  • Subject or Authorized Representative is unable to provide informed consent.
  • Subject is pregnant or breastfeeding or intends to get pregnant within 28 days of enrolling into the study.
  • Subject is of childbearing potential and does not have a negative pregnancy test.
  • Subject is < 18 years of age.
  • Subject has a known allergy to ART-123 or any components of the drug product.
  • Subject is unwilling to allow transfusion of blood or blood products.
  • Subject has an advance directive to withhold life-sustaining treatment.
  • Subject has had previous treatment with ART-123.
  • Body weight ≥ 175 kg.
  • Platelets < 30,000/ mm3 for any reason, PT prolongation or thrombocytopenia that is not due to sepsis.
  • Any surgery that is potentially hemorrhagic (e.g. intra-thoracic, intra-abdominal or non-traumatic orthopedic surgery of the femur or pelvis) that is completed within 12 hours prior to first dose of study drug, or ongoing impairment of hemostasis as a result of one of these procedures
  • History of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding within 3 months prior to consent.
  • Cerebral Vascular Accident (CVA) within 3 months prior to consent.
  • Any history of intracerebral arteriovenous malformation (AVM), cerebral aneurysm, or mass lesions of the central nervous system.
  • History of congenital bleeding diathesesor anatomical anomaly that predisposes to hemorrhage (e.g. hemophilia, hereditary hemorrhagic telangiectasia).
  • Significant gastrointestinal bleeding within 6 weeks prior to consent.
  • Subject is diagnosed with a known medical condition associated with a hypercoagulable state.
  • Child-Pugh score of 10-15 (Class C)
  • Portosystemic hypertension or known history of bleeding esophageal varices.
  • History of solid organ, allogeneic bone marrow, or stem cell transplantation within the 6 months prior to consent.
  • Acute pancreatitis where infection has not been documented by a positive blood or abdominal fluid culture or gram stain consistent with bacterial infection.
  • Subjects with renal dysfunction defined as (a) Chronic renal failure requiring renal replacement therapy (RRT), or (b) Acute renal failure with onset of oliguria (urine output < 0.3 ml/kg/hr) > 48 hours prior to first dose of study drug whether receiving RRT or not
  • Use of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics within the 72 hours prior to first does of study drug.
  • Life expectancy < 90 days.
  • Current use of any chemotherapy agent likely to cause myeloablation (severe or complete depletion of bone marrow).
  • Participation in another research study involving an investigational agent within 30 days prior to consent or projected study participation during the 28 days post study randomization.
  • Confirmed or suspected endocarditis

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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.
Placebo Comparator: Placebo
Drug: Placebo
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.
Active Comparator: ART-123
Drug: ART-123
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Other Names:
  • human recombinant thrombomodulin
  • thrombomodulin alfa

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
Number of Participants With 28-Day All-cause Mortality
Time Frame: 28 days
28-Day All-cause Mortality
28 days
Number of Participants With On-Treatment Serious Major Bleeding Events
Time Frame: Through Study Day 28
On-treatment Serious Major Bleeding Events collected as Serious Adverse Events and defined as: any intracranial hemorrhage, any life-threatening bleeding, any bleeding event classified as serious by the Investigator (e.g., resulting in permanent morbidity), or any bleeding that required the administration of 1440 ml (typically 6 units) of packed red cells over two consecutive days. (Investigator assessment for seriousness criteria.)
Through Study Day 28

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
Follow up All-cause Mortality at 3 Months
Time Frame: 3 months
Follow up all-cause mortality at 3 months
3 months
Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction
Time Frame: 28 days
Resolution of organ dysfunction as measured through day 28 by shock free, ventilator free, dialysis free plus alive days.
28 days
Number of Participants With Anti-drug Antibodies
Time Frame: 18 months
Presence of Anti-drug antibodies up to 18 months
18 months

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.
Asahi Kasei Pharma America Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: David Fineberg, M.D., Asahi Kasei Pharma America Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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.
October 29, 2012

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.
April 5, 2018

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 28, 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).
May 11, 2012

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.
May 14, 2012

First Posted (Estimate)

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.
May 15, 2012

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 21, 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 18, 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.
March 1, 2020

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.
  • 3-001

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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