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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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.
Secondary ID [1] 0 0
3-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe Sepsis 0 0
Coagulopathy 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Injuries and Accidents 0 0 0 0
Poisoning
Blood 0 0 0 0
Other blood disorders
Infection 0 0 0 0
Other infectious diseases
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With 28-Day All-cause Mortality
Timepoint [1] 0 0
28 days
Primary outcome [2] 0 0
Number of Participants With On-Treatment Serious Major Bleeding Events
Timepoint [2] 0 0
Through Study Day 28
Secondary outcome [1] 0 0
Follow up All-cause Mortality at 3 Months
Timepoint [1] 0 0
3 months
Secondary outcome [2] 0 0
Number of Event Free and Alive Days to Measure Resolution of Organ Dysfunction
Timepoint [2] 0 0
28 days
Secondary outcome [3] 0 0
Number of Participants With Anti-drug Antibodies
Timepoint [3] 0 0
18 months

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
28/02/2019
Sample size
Target
Accrual to date
Final
816
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,VIC
Recruitment hospital [1] 0 0
Prince of Wales Hospital - Randwick
Recruitment hospital [2] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment hospital [3] 0 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [4] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [5] 0 0
Bendigo Hospital - Bendigo
Recruitment hospital [6] 0 0
Monash Medical Centre - Clayton
Recruitment hospital [7] 0 0
Dandenong Hospital Monash Health - Dandenong
Recruitment hospital [8] 0 0
Western Hospital - Footscray
Recruitment hospital [9] 0 0
Austin Health - Heidelberg
Recruitment hospital [10] 0 0
Sunshine Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Randwick
Recruitment postcode(s) [2] 0 0
- Herston
Recruitment postcode(s) [3] 0 0
- Woolloongabba
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
- Bendigo
Recruitment postcode(s) [6] 0 0
- Clayton
Recruitment postcode(s) [7] 0 0
3175 - Dandenong
Recruitment postcode(s) [8] 0 0
- Footscray
Recruitment postcode(s) [9] 0 0
- Heidelberg
Recruitment postcode(s) [10] 0 0
3021 - Melbourne
Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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Oklahoma
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Utah
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Argentina
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Cordoba
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Belgium
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Antwerpen
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Belgium
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Arlon
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Brussels
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Lille
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Newtown
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Peru
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Sochi
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St. Petersburg
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Serbia
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Nis
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A Coruña
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Barcelona
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Sabadell
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Spain
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Tarragona
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Taiwan
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Tainan
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Taiwan
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Taichung
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Taiwan
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Taipei
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United Kingdom
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Birmingham
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United Kingdom
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Hull
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Liverpool
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Manchester
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United Kingdom
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Plymouth

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Asahi Kasei Pharma America Corporation
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of the study is to evaluate if ART-123 given to patients who have severe sepsis
can decrease mortality.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01598831
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
David Fineberg, M.D.
Address 0 0
Asahi Kasei Pharma America Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01598831