A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

Completed · Phase 3

Conditions studied: Hereditary Angioedema Types I and II

In brief

The aim of this study is to assess the long-term safety of C1-esterase inhibitor (C1-INH) in preventing hereditary angioedema (HAE) attacks when it is administered under the skin of subjects with HAE. The safety of participating subjects will be assessed for up to 54 weeks. The long-term efficacy of C1-INH will also be assessed. Each eligible subject will enter the treatment phase, wherein subjects will be randomized to treatment with either low- or medium-volume C1-INH. Subjects who have an insufficient treatment response during the study will be given an opportunity to undergo a dose increase. The study aims to enroll eligible subjects who completed study CSL830\_3001 (NCT01912456). Subjects who did not participate in study CSL830\_3001 may also participate, if eligible and if space permits. Subjects from the United States (US) who complete Treatment Period 2 will be allowed to participate in an Extension Period. During the Extension Period participating US subjects will continue to receive treatment with open-label CSL830 for up to an additional 88 weeks.

Key facts

Study ID

NCT02316353

Run by

CSL Behring

People needed

126

Starts

2014-12-31

Expected to finish

2017-09-21

Last updated by the study team

2018-11-14

Who can join

Age: 6 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Males or females aged 6 years or older.
• A confirmed diagnosis of HAE type I or II.
• HAE attacks over a consecutive 2-month period that required acute treatment, medical attention, or caused significant functional impairment.
• For subjects who have used oral therapy for prophylaxis against HAE attacks within 3 months of first study visit: use of a stable regimen within 3 months of the first study visit.

You may not qualify if…

• Incurable malignancies.
• Any clinical condition that will interfere with the evaluation of C1-INH therapy.
• Clinically significant history of poor response to C1-esterase therapy for the management of HAE.
• Suspected or confirmed diagnosis of acquired HAE or HAE with normal C1-INH.
• Inability to have HAE managed pharmacologically with on-demand treatment.

Where it is running

• Study Site — Birmingham, Alabama, United States
• Study Site — Scottsdale, Arizona, United States
• Study Site — La Jolla, California, United States
• Study Site — Orange, California, United States
• Study Site — Walnut Creek, California, United States
• Study Site — Chevy Chase, Maryland, United States
• Study Site — Cincinnati, Ohio, United States
• Study Site — Tulsa, Oklahoma, United States
• Study Site — Portland, Oregon, United States
• Study Site — Hershey, Pennsylvania, United States
• Study Site — Dallas, Texas, United States
• Study Site — Richmond, Virginia, United States
• Study Site — Campbelltown, New South Wales, Australia
• Study Site — Hamilton, Ontario, Canada
• Study Site — Ottawa, Ontario, Canada
• Study Site — Toronto, Ontario, Canada
• Study Site — Québec, Canada
• Study Site — Pilsen, Czechia
• Study Site — Mörfelden-Walldorf, Hesse, Germany
• Study Site — Berlin, Germany
• Study Site — Frankfurt, Germany
• Study Site — Mainz, Germany
• Study Site — Budapest, Hungary
• Study Site — Tel Aviv, Israel
• Study Site — Tel Litwinsky, Israel

Full record on ClinicalTrials.gov

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