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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/NCT03712228
Registration number
NCT03712228
Ethics application status
Date submitted
17/10/2018
Date registered
19/10/2018
Date last updated
8/11/2022
Titles & IDs
Public title
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
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Scientific title
A Multicenter, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy, Pharmacokinetics, and Safety of CSL312 in Subjects With Hereditary Angioedema
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Secondary ID [1]
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2018-000605-24
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Secondary ID [2]
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CSL312_2001
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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 - Factor XIIa antagonist monoclonal antibody
Treatment: Drugs - Placebo
Placebo Comparator: Placebo - Subjects with C1-INH HAE receiving buffer only
Active Comparator: CSL312 (low) - Subjects with C1-INH HAE receiving low dose CSL312
Active Comparator: CSL312 (med) - Subjects with C1-INH HAE receiving medium dose CSL312
Active Comparator: CSL312 (high) - Subjects with C1-INH HAE receiving high dose CSL312
Active Comparator: CSL312 (med/high) - Subjects with C1-INH HAE receiving medium/high dose CSL312
Other interventions: Factor XIIa antagonist monoclonal antibody
Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
Treatment: Drugs: Placebo
Buffer without active ingredient
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Intervention code [1]
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Other interventions
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Intervention code [2]
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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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The Mean Time Normalized Number of HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [1]
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The time-normalized number of HAE attacks per month during Treatment Period 1 for a subject was calculated as the (number of HAE attacks / length of subject's evaluation period in days) * 30.4375
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Timepoint [1]
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13 weeks
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Secondary outcome [1]
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The Number of Responder Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [1]
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Response is defined as a = 50% relative reduction in the time-normalized number of HAE attacks (per month) during Treatment Period 1 compared to each subject's time-normalized number of HAE attacks (per month) during the Run-in Period
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Timepoint [1]
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13 weeks
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Secondary outcome [2]
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The Percentage of Responder Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [2]
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Response is defined as a = 50% relative reduction in the time-normalized number of HAE attacks (per month) during Treatment Period 1 compared to each subject's time-normalized number of HAE attacks (per month) during the Run-in Period.
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Timepoint [2]
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13 weeks
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Secondary outcome [3]
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The Number of HAE Attack-free Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [3]
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Timepoint [3]
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13 weeks
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Secondary outcome [4]
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The Percentage of HAE Attack-free Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [4]
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Timepoint [4]
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13 weeks
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Secondary outcome [5]
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The Number of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [5]
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Timepoint [5]
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13 weeks
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Secondary outcome [6]
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The Percentage of Mild, Moderate or Severe HAE Attacks in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [6]
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Timepoint [6]
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13 weeks
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Secondary outcome [7]
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The Mean Time-normalized Number of Mild, Moderate or Severe HAE Attacks Per Month in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [7]
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The time-normalized number of HAE attacks per month during Treatment Period 1 for a subject was calculated as the (number of HAE attacks / length of subject's evaluation period in days) * 30.4375
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Timepoint [7]
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13 weeks
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Secondary outcome [8]
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The Number of Subjects With at Least One (1) HAE Attack Treated With On-demand HAE Medication, in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [8]
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Timepoint [8]
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13 weeks
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Secondary outcome [9]
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The Percentage of Subjects With at Least One (1) HAE Attack Treated With On-demand HAE Medication, in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [9]
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Timepoint [9]
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13 weeks
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Secondary outcome [10]
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Maximum Concentration (Cmax) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [10]
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Timepoint [10]
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13 weeks
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Secondary outcome [11]
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Area Under the Concentration-time Curve in 1 Dosing Interval (AUC0-tau) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [11]
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Timepoint [11]
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13 weeks
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Secondary outcome [12]
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Time of Maximum Concentration (Tmax) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [12]
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Timepoint [12]
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13 weeks
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Secondary outcome [13]
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Terminal Elimination Half-life (T1/2) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [13]
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Timepoint [13]
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13 weeks
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Secondary outcome [14]
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Clearance (CL/F) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [14]
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Timepoint [14]
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13 weeks
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Secondary outcome [15]
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Volume of Distribution During the Elimination Phase (Vz/F) of CSL312 in Subjects With C1-INH HAE During Treatment Period 1
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Assessment method [15]
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Timepoint [15]
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13 weeks
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Secondary outcome [16]
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The Number of Subjects With C1-INH HAE With Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESI), Injection Site Reactions (ISRs), Binding Antibodies to CSL312 During Treatment Period 1
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Assessment method [16]
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Adverse events of special interest is defined as anaphylaxis, thromboembolic events, and bleeding events.
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Timepoint [16]
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13 weeks
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Eligibility
Key inclusion criteria
- Male or female
- Aged = 18 to = 65 years
- A diagnosis of C1-INH HAE or FXII/PLG HAE;
- For subjects with C1-INH HAE: = 4 HAE attacks over a consecutive 2-month period during
the 3 months before Screening, as documented in the subject's medical record.
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Minimum age
18
Years
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Maximum age
65
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
- History of clinically significant arterial or venous thrombosis, or current clinically
significant prothrombotic risk
- History of an uncontrolled, abnormal bleeding event due to a coagulopathy, or a
current clinically significant coagulopathy or clinically significant risks for
bleeding events
- Known incurable malignancies
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Study design
Purpose of the study
Prevention
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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
29/10/2018
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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
15/10/2021
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Sample size
Target
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Accrual to date
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Final
44
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Campbelltown Hospital - Campbelltown
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Recruitment postcode(s) [1]
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2560 - Campbelltown
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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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California
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Country [2]
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United States of America
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State/province [2]
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Colorado
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Country [3]
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United States of America
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State/province [3]
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Maryland
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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Pennsylvania
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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Canada
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State/province [7]
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Alberta
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Country [8]
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Canada
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State/province [8]
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Ontario
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Country [9]
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Germany
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State/province [9]
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Berlin
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Country [10]
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Germany
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State/province [10]
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Frankfurt
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Country [11]
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Germany
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State/province [11]
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Mainz
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Country [12]
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Germany
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State/province [12]
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Mörfelden-Walldorf
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Country [13]
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Israel
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State/province [13]
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Ashkelon
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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 is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to
investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to
prevent attacks in subjects with HAE.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT03712228
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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 LLC
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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/NCT03712228
Download to PDF