A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)



Status:Recruiting
Conditions:Skin and Soft Tissue Infections
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 65
Updated:4/6/2019
Start Date:October 29, 2018
End Date:September 2020
Contact:Trial Registration Coordinator
Email:clinicaltrials@cslbehring.com
Phone:610.878.4000

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A Multicenter, Randomized, Placebo-controlled, Parallel-arm Study to Investigate the Efficacy, Pharmacokinetics, and Safety of CSL312 in Subjects With Hereditary Angioedema

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.


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.

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
We found this trial at
11
sites
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Toledo, OH
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Birmingham, Alabama 35209
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Campbelltown, New South Wales 2560
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Centennial, Colorado 80112
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Chevy Chase, Maryland 20815
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Dallas, Texas 75231
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Hershey, Pennsylvania 17033
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Hershey, PA
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New York, New York 10029
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New York, NY
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Orange, California 92868
Phone: 610-400-1000
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Orange, CA
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Saint Louis, Missouri 63110
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Saint Louis, MO
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Walnut Creek, California 94598
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Walnut Creek, CA
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