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

Completed · Phase 2 · Has a placebo group

Conditions studied: Hereditary Angioedema

In brief

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.

Key facts

Study ID

NCT03712228

Run by

CSL Behring

People needed

44

Starts

2018-10-29

Expected to finish

2021-10-15

Last updated by the study team

2022-11-08

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Donald S. Levy — Orange, California, United States
• Allergy & Asthma Clinical Research — Walnut Creek, California, United States
• Immunoe Health Centers — Centennial, Colorado, United States
• Institute for Asthma and Allergy — Chevy Chase, Maryland, United States
• The Mount Sinai Hospital — New York, New York, United States
• Pennsylvania State University — Hershey, Pennsylvania, United States
• AARA Research Center — Dallas, Texas, United States
• Campbelltown Hospital — Campbelltown, New South Wales, Australia
• University of Alberta — Edmonton, Alberta, Canada
• Allergy and Clinical Immunology McMaster University — Hamilton, Ontario, Canada
• Ottawa Allergy Research Corp — Ottawa, Ontario, Canada
• Charité Universitätsmedizin Berlin — Berlin, Germany
• Universitätsklinikum Frankfurt Goethe-Universität — Frankfurt, Germany
• Hautklinik und Poliklinik der Universitätsklinik Mainz — Mainz, Germany
• HZRM Hämophilie Zentrum Rhein Main GmbH — Mörfelden-Walldorf, Germany
• Barzilai University Medical Center — Ashkelon, Israel

Full record on ClinicalTrials.gov

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