Treatment of Hereditary Angioedema Prodrome with Recombinant C1-esterase Inhibitor (Ruconest)

Completed · Phase 4

Conditions studied: Hereditary Angioedema

In brief

To assess the efficacy of recombinant human C1-esterase inhibitor in the management of HAE prodrome for preventing the progression from prodrome to an acute angioedema attacks. Subjects will either receive Ruconest after the first 2 prodromes or during the last 2 prodromes. 5 clinic visits will occur within 24 hours of a prodrome. Subjects will complete prodrome severity and angioedema attack diaries

Key facts

Study ID

NCT06690047

Run by

Bernstein Clinical Research Center

People needed

5

Starts

2018-08-14

Expected to finish

2022-04-28

Last updated by the study team

2024-11-15

Who can join

Age: 14 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior diagnosis of HAE Type 1 and 2,
• One or more HAE attacks per month,
• History of 4 prodromes that proceed to angioedema attacks

You may not qualify if…

• History of thrombosis or arterial/venous thromboembolic attacks
• History of atherosclerosis, morbid obesity, immobility
• History of allergy to rabbits or products from rabbits
• History of life-threatening immediate allergic reactions to C1 esterase inhibitor preparations

Where it is running

• Clinical Research Center of Alabama — Birmingham, Alabama, United States
• Bernstein Clinical Research Center, LLC — Cincinnati, Ohio, United States

Full record on ClinicalTrials.gov

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