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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/NCT04739059
Registration number
NCT04739059
Ethics application status
Date submitted
1/02/2021
Date registered
4/02/2021
Date last updated
7/06/2024
Titles & IDs
Public title
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
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Scientific title
An Open-label Study to Evaluate the Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema
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Secondary ID [1]
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2020-003918-12
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Secondary ID [2]
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CSL312_3002
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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:
Hereditary Angioedema
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Human Genetics and Inherited Disorders
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Other human genetics and inherited disorders
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Blood
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Other blood disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - CSL312
Experimental: CSL312 - Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody administered subcutaneously
Other interventions: CSL312
Fully human immunoglobulin G subclass 4/lambda recombinant inhibitor monoclonal antibody
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Intervention code [1]
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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 subjects with treatment emergent adverse events (TEAEs)
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Assessment method [1]
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Timepoint [1]
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Up to 45 months
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Primary outcome [2]
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Percentage of subjects with TEAEs
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Assessment method [2]
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Timepoint [2]
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Up to 45 months
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Primary outcome [3]
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TEAEs rates per injection
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Assessment method [3]
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Timepoint [3]
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Up to 45 months
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Primary outcome [4]
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TEAEs rates per subject year
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Assessment method [4]
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Timepoint [4]
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Up to 45 months
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Secondary outcome [1]
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The time-normalized number (per month and year) of Hereditary Angioedema (HAE attacks) for the entire study
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Assessment method [1]
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Timepoint [1]
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Up to 43 months
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Secondary outcome [2]
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The percentage reduction and the number of subjects experiencing at least = 50% = 70%, = 90 or equal to 100% (attack free) reduction in the time-normalized number of HAE attacks on Treatment compared to Run-in Period
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Assessment method [2]
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Timepoint [2]
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Up to 43 months
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Secondary outcome [3]
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The time-normalized number (per month and year) of HAE attacks requiring on-demand treatment in subjects on treatment
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Assessment method [3]
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Timepoint [3]
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Up to 43 months
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Secondary outcome [4]
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The time-normalized number (per month and year) of moderate and/or severe HAE attacks in subjects on treatment
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Assessment method [4]
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Timepoint [4]
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Up to 43 months
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Secondary outcome [5]
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Number and percentage of subjects rating their response to therapy as good or excellent
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Assessment method [5]
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Timepoint [5]
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Up to 43 months
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Secondary outcome [6]
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The number and percentage of subjects experiencing TEAEs
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Assessment method [6]
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Timepoint [6]
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Up to 45 months
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Secondary outcome [7]
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The number and percentage of subjects experiencing adverse events of special interest (AESIs)
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Assessment method [7]
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Timepoint [7]
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Up to 45 months
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Secondary outcome [8]
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The number and percentage of subjects experiencing serious adverse events (SAEs), including deaths
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Assessment method [8]
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Timepoint [8]
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Up to 45 months
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Secondary outcome [9]
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The number and percentage of subjects experiencing CSL312 induced anti-CSL312 antibodies
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Assessment method [9]
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Timepoint [9]
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Up to 45 months
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Eligibility
Key inclusion criteria
- Males and females aged = 12 years
- Diagnosed with clinically confirmed C1-INH HAE
- Experienced = 3 HAE attacks during the 3 months before Screening
- Participated in the Run-in Period for at least 1 month (CSL312-naïve subjects only)
- Experienced at least an average of 1 HAE attack per month during the Run-in Period
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Minimum age
12
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
- Concomitant diagnosis of another form of angioedema, such as idiopathic or acquired
angioedema or recurrent angioedema associated with urticaria
- Use of C1-INH products, androgens, antifibrinolytics or other small molecule
medications for routine prophylaxis against HAE attacks at least 2 weeks before the
first day of the Run-in Period
- Use of monoclonal antibodies such as lanadelumab (Takhzyro®) 3 months before the first
day of the Run-in Period.
- Female subjects use estrogen-containing oral contraceptives or hormone replacement
therapy within 4 weeks prior to screening
- Female or male subjects who are fertile and sexually active not using or not willing
to use an acceptable method of contraception to avoid pregnancy during the study and
for 30 days after receipt of the last dose of CSL312
- Pregnant, breastfeeding, or not willing to cease breastfeeding
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Study design
Purpose of the study
Prevention
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Allocation to intervention
N/A
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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
Single group
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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
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
29/03/2021
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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
1/11/2025
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Actual
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Sample size
Target
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Accrual to date
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Final
171
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,West Australi
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Recruitment hospital [1]
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Campbelltown Hospital / Western Sydney University - Campbelltown
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Recruitment hospital [2]
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The Alfred Hospital - Melbourne
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Recruitment hospital [3]
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Fiona Stanley Hospital, Department of Clinical Immunology - Murdoch
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment postcode(s) [3]
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6150 - Murdoch
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Recruitment outside Australia
Country [1]
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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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Arkansas
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United States of America
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California
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Country [5]
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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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Ohio
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Country [7]
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United States of America
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Pennsylvania
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United States of America
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Texas
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Czechia
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Brno
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Czechia
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Praha 5
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Germany
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Berlin
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Germany
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Frankfurt
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Germany
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Mainz
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Germany
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Mörfelden-Walldorf
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Hong Kong
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Hong Kong
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Hungary
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Budapest
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Israel
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Ashkelon
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Japan
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State/province [21]
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Daikakuji Yaizu-shi
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Japan
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State/province [22]
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Edobashi, Tsu-shi
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Japan
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State/province [23]
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Hongo Bunkyo-ku
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Japan
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Kamoda Kawagoe-shi
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Japan
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Kawasaki-shi
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Japan
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Kugenumaishigami, Fujisawa-shi
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Japan
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Matsubara Soka-shi
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Japan
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Midoricho, Tachikawa-shi
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Japan
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Nebeshima, Saga-shi
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Japan
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State/province [30]
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Osaka-shi
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Country [31]
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Netherlands
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Amsterdam
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Country [32]
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New Zealand
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Auckland
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Russian Federation
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Moscow
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Spain
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Barcelona
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Spain
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Madrid
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Taiwan
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Taichung City
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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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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as
garadacimab) when administered subcutaneously (SC)
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04739059
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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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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
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Address
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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/NCT04739059
Download to PDF