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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/NCT05130970
Registration number
NCT05130970
Ethics application status
Date submitted
12/11/2021
Date registered
23/11/2021
Date last updated
9/02/2024
Titles & IDs
Public title
CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
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Scientific title
A Randomized, Double-blind, Placebo-controlled, Study to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics of CSL312 in Subjects With Idiopathic Pulmonary Fibrosis
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Secondary ID [1]
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2021 003162 12
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Secondary ID [2]
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CSL312_2002
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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:
Idiopathic Pulmonary Fibrosis
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - CSL312
Treatment: Drugs - Placebo
Experimental: CSL312 - Administered IV and SC
Placebo Comparator: Placebo - Administered IV and SC
Treatment: Drugs: CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
Treatment: Drugs: Placebo
Same as the CSL312 formulation buffer
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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 treatment-emergent serious adverse events (SAEs) for CSL312 or placebo
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Assessment method [1]
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Timepoint [1]
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Up to 22 weeks
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Primary outcome [2]
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Percent of participants with SAEs for CSL312 or placebo
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Assessment method [2]
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Timepoint [2]
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Up to 22 weeks
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Primary outcome [3]
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Number of participants with treatment-emergent adverse events of special interest (AESIs) for CSL312 or placebo
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Assessment method [3]
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Timepoint [3]
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Up to 22 weeks
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Primary outcome [4]
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Percent of participants with AESIs for CSL312 or placebo
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Assessment method [4]
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Timepoint [4]
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Up to 22 weeks
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Primary outcome [5]
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Number of participants with treatment-emergent CSL312 induced antidrug antibodies (ADAs)
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Assessment method [5]
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Timepoint [5]
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Up to 14 weeks
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Primary outcome [6]
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Percent of participants with CSL312 induced ADAs
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Assessment method [6]
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Timepoint [6]
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Up to 14 weeks
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Primary outcome [7]
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Number of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
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Assessment method [7]
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Timepoint [7]
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Up to 14 weeks
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Primary outcome [8]
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Percent of participants with treatment-emergent clinically significant abnormalities in laboratory assessments that are reported as adverse events (AEs) for CSL312 or placebo
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Assessment method [8]
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Timepoint [8]
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Up to 14 weeks
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Secondary outcome [1]
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Trough plasma concentration (Ctrough) after subcutaneous (SC) administration of CSL312
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Assessment method [1]
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Timepoint [1]
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Up to 14 weeks
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Secondary outcome [2]
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Maximum plasma concentration (Cmax) (last SC dosing interval only) of CSL312
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Assessment method [2]
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Timepoint [2]
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Up to 14 weeks
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Secondary outcome [3]
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Time to maximum plasma concentration (Tmax) (last SC dosing interval only) of CSL312
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Assessment method [3]
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Timepoint [3]
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Up to 14 weeks
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Secondary outcome [4]
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Area under the plasma concentration-time curve after the first dose interval (AUC0-tau) (last SC dosing interval only) of CSL312
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Assessment method [4]
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Timepoint [4]
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Up to 14 weeks
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Secondary outcome [5]
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Ctrough after intravenous (IV) administration of CSL312
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Assessment method [5]
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Timepoint [5]
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Up to 8 days
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Secondary outcome [6]
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Cmax after IV administration of CSL312
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Assessment method [6]
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Timepoint [6]
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Up to 8 days
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Secondary outcome [7]
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Tmax after IV administration of CSL312
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Assessment method [7]
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Timepoint [7]
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Up to 8 days
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Secondary outcome [8]
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Mean change from Baseline in FXIIa-mediated kallikrein activity of CSL312
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Assessment method [8]
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Timepoint [8]
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Up to 14 weeks
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Secondary outcome [9]
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Mean percentage of Baseline in FXIIa-mediated kallikrein activity of CSL312
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Assessment method [9]
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Timepoint [9]
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Up to 14 weeks
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Eligibility
Key inclusion criteria
- Male or female patients = 40 years of age
- Documented diagnosis of IPF
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Minimum age
40
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
- History of clinically significant cardiovascular disease, including myocardial
infarction, unstable ischemic heart disease, congestive heart failure, or angina
during the 6 months before screening
- Sinoatrial or atrioventricular block, uncontrolled hypertension
- Active bleeding or current clinically significant coagulopathy
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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 2
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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
27/01/2022
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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
2/01/2024
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Sample size
Target
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Accrual to date
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Final
81
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Royal Adelaide Hospital - Adelaide
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment outside Australia
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United States of America
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State/province [1]
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Alabama
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United States of America
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Arizona
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United States of America
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California
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United States of America
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Florida
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Country [5]
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United States of America
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Kansas
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United States of America
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Maryland
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United States of America
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Missouri
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United States of America
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New York
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United States of America
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North Carolina
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Ohio
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United States of America
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Oklahoma
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Pennsylvania
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Tennessee
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United States of America
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State/province [14]
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Texas
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Austria
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Graz
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Austria
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Linz
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Belgium
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Leuven
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Belgium
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Liège
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Canada
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Ontario
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Denmark
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Odense
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Germany
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Coswig
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Germany
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Essen
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Germany
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Hannover
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Germany
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Wuppertal
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Italy
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Foggia
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Poland
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Bialystok
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Poland
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Nowa Sol
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Poland
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Wroclaw
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Spain
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Barcelona
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Spain
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Cadiz
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United Kingdom
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MD
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United Kingdom
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Birmingham
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United Kingdom
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State/province [33]
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Londonderry
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Country [34]
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United Kingdom
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Manchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
CSL Behring
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled,
parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD)
of CSL312 in subjects with idiopathic pulmonary fibrosis (IPF).
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05130970
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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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Study Director
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Address
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CSL Behring
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Phone
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Fax
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Email
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Contact person for public queries
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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/NCT05130970
Download to PDF