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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/NCT04848272
Registration number
NCT04848272
Ethics application status
Date submitted
13/04/2021
Date registered
19/04/2021
Date last updated
17/04/2024
Titles & IDs
Public title
Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
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Scientific title
Inhibition of Plasma Kallikrein as a New Therapy for Lung Injury
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Secondary ID [1]
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SVI-01
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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:
Lung Injury
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Injuries and Accidents
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Other injuries and accidents
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Lanadelumab
Other interventions - Saline control
Placebo Comparator: Saline control - Saline control
Experimental: Lanadelumab 30 mg - Lanadelumab 30 mg
Experimental: Lanadelumab 100 mg - Lanadelumab 100 mg
Experimental: Lanadelumab 300 mg - Lanadelumab 300 mg
Treatment: Drugs: Lanadelumab
Monoclonal antibody that targets active plasma kallikrein
Other interventions: Saline control
Saline control
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Intervention code [1]
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Treatment: Drugs
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Intervention code [2]
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Other interventions
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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 Treatment-Related Adverse Events
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Assessment method [1]
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Blood gases, pH, bicarbonate, carbon dioxide and lactic acid levels. If the participant is receiving mechanical ventilation, the ventilator settings will be constantly monitored.
Chest X-ray, as indicated. Constant monitoring of haemodynamics (pulse rate, blood pressure) via an arterial cannula, use of vasoactive medications, and constant monitoring of ECG. Fluid balance, including urine output. Serum creatinine, electrolytes, liver function, creatinine kinase, FBE and coagulation will be measured daily or less frequently as decided by the treating team.
If there is suspicion of infection, then appropriate samples will be taken for microbiological examination.
Neurological function will be assessed several times per day.
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Timepoint [1]
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28 days
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Secondary outcome [1]
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Blood bradykinin concentration
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Assessment method [1]
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Blood bradykinin concentration
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Timepoint [1]
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0, 6, 12, and 24 hours
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Eligibility
Key inclusion criteria
- Age >18 years admitted to the ICU with primary diagnosis of lung injury. The criteria
for the diagnosis of lung injury include five principal elements: hypoxemia (blood
oxygen saturation (PaO2) =92% when breathing ambient air, ratio of PaO2 to the
fraction of inspired oxygen (FiO2) =300), diffuse pulmonary infiltrates on chest
radiographs, decreased lung compliance, and the absence of congestive heart failure.
- Both males and females will be recruited in the proportion in which they are admitted
to the ICU with lung injury.
- Arterial cannula in place as part of usual care for the measurement of blood gases.
- Patients may or may not be intubated and mechanically ventilated.
- Able to provide informed consent, or if unable to do so, a responsible person:
medical treatment decision maker is available (by telephone if necessary) who can be
approached to seek consent.
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Minimum age
18
Years
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Maximum age
90
Years
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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
- Other causes of lung infiltrates: pulmonary oedema, alveolar haemorrhage, adverse drug
reactions, radiation injury and the idiopathic pneumonitis syndrome.
- Significant dysfunction of non-pulmonary organs in the opinion of the treating ICU
consultant.
- Death is deemed imminent or inevitable or there is underlying disease with a life
expectancy of less than 90 days.
- Previously enrolled in this study.
- Enrolled in another study.
- Usually receives home oxygen.
- Usually receives any type of assisted ventilation at home. e.g. continuous positive
airway pressure for obstructive sleep apnoea.
- Pregnant or might be pregnant. Women aged 18 to 49 are excluded unless there is
documented menopause, hysterectomy or surgical sterilisation, or a pregnancy test is
negative.
- Objection from the treating clinician.
- Consent refused by the patient or substitute decision maker.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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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
9/08/2021
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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
1/12/2024
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Actual
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Sample size
Target
48
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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St Vincent's Hospital Melbourne - Melbourne
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Recruitment postcode(s) [1]
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3065 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
St Vincent's Institute of Medical Research
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
Phase 1 study investigating safety of lanadelumab administration to patients with lung injury
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04848272
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04848272
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