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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01598831
Registration number
NCT01598831
Ethics application status
Date submitted
11/05/2012
Date registered
15/05/2012
Date last updated
21/04/2020
Titles & IDs
Public title
Phase 3 Safety and Efficacy Study of ART-123 in Subjects With Severe Sepsis and Coagulopathy
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Scientific title
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.
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Secondary ID [1]
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0
3-001
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Severe Sepsis
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0
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Coagulopathy
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Condition category
Condition code
Infection
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0
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0
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Studies of infection and infectious agents
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Inflammatory and Immune System
0
0
0
0
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Other inflammatory or immune system disorders
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Injuries and Accidents
0
0
0
0
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Poisoning
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Blood
0
0
0
0
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Other blood disorders
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Infection
0
0
0
0
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Other infectious diseases
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Cardiovascular
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0
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Blood
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0
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0
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Clotting disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ART-123
Treatment: Drugs - Placebo
Active comparator: ART-123 -
Placebo comparator: Placebo -
Treatment: Drugs: ART-123
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
Treatment: Drugs: Placebo
Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants With 28-Day All-cause Mortality
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Assessment method [1]
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28-Day All-cause Mortality
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Timepoint [1]
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28 days
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Primary outcome [2]
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Number of Participants With On-Treatment Serious Major Bleeding Events
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Assessment method [2]
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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.)
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Timepoint [2]
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Through Study Day 28
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Secondary outcome [1]
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Follow up All-cause Mortality at 3 Months
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Assessment method [1]
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Follow up all-cause mortality at 3 months
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Timepoint [1]
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3 months
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Secondary outcome [2]
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Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction
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Assessment method [2]
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Resolution of organ dysfunction as measured through day 28 by shock free, ventilator free, dialysis free plus alive days.
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Timepoint [2]
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28 days
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Secondary outcome [3]
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Number of Participants With Anti-drug Antibodies
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Assessment method [3]
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Presence of Anti-drug antibodies up to 18 months
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Timepoint [3]
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18 months
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/10/2012
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
28/02/2019
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Sample size
Target
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Accrual to date
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Final
816
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
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Recruitment hospital [1]
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Prince of Wales Hospital - Randwick
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Royal Brisbane and Women's Hospital - Herston
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Princess Alexandra Hospital - Woolloongabba
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Royal Adelaide Hospital - Adelaide
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Bendigo Hospital - Bendigo
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Monash Medical Centre - Clayton
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Dandenong Hospital Monash Health - Dandenong
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Western Hospital - Footscray
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Austin Health - Heidelberg
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Sunshine Hospital - Melbourne
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- Randwick
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- Herston
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- Woolloongabba
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Recruitment postcode(s) [4]
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5000 - Adelaide
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- Bendigo
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- Clayton
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3175 - Dandenong
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- Footscray
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- Heidelberg
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Recruitment postcode(s) [10]
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3021 - Melbourne
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Recruitment outside Australia
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United States of America
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Alabama
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Michigan
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Tarragona
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Taiwan
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State/province [114]
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Tainan
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Country [115]
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Taiwan
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State/province [115]
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Taichung
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Country [116]
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Taiwan
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State/province [116]
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Taipei
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Country [117]
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United Kingdom
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State/province [117]
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Birmingham
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Country [118]
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United Kingdom
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State/province [118]
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Hull
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Country [119]
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United Kingdom
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Liverpool
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United Kingdom
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Manchester
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United Kingdom
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Plymouth
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Asahi Kasei Pharma America Corporation
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis can decrease mortality.
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Trial website
https://clinicaltrials.gov/study/NCT01598831
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Trial related presentations / publications
Levi M, Vincent JL, Tanaka K, Radford AH, Kayanoki T, Fineberg DA, Hoppensteadt D, Fareed J. Effect of a Recombinant Human Soluble Thrombomodulin on Baseline Coagulation Biomarker Levels and Mortality Outcome in Patients With Sepsis-Associated Coagulopathy. Crit Care Med. 2020 Aug;48(8):1140-1147. doi: 10.1097/CCM.0000000000004426. Vincent JL, Francois B, Zabolotskikh I, Daga MK, Lascarrou JB, Kirov MY, Pettila V, Wittebole X, Meziani F, Mercier E, Lobo SM, Barie PS, Crowther M, Esmon CT, Fareed J, Gando S, Gorelick KJ, Levi M, Mira JP, Opal SM, Parrillo J, Russell JA, Saito H, Tsuruta K, Sakai T, Fineberg D; SCARLET Trial Group. Effect of a Recombinant Human Soluble Thrombomodulin on Mortality in Patients With Sepsis-Associated Coagulopathy: The SCARLET Randomized Clinical Trial. JAMA. 2019 May 28;321(20):1993-2002. doi: 10.1001/jama.2019.5358.
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Public notes
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Contacts
Principal investigator
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David Fineberg, M.D.
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Asahi Kasei Pharma America Corporation
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
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Other Details
Attachment
Study protocol
https://cdn.clinicaltrials.gov/large-docs/31/NCT01598831/Prot_000.pdf
Statistical analysis plan
https://cdn.clinicaltrials.gov/large-docs/31/NCT01598831/SAP_001.pdf
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01598831
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