Hereditary Angioedema Clinical Trial
Official title:
A Phase III Randomized, Double-blind, Placebo-controlled Study With an Open-label Extension Evaluating the Efficacy, Safety and Immunogenicity of Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks of Angioedema in Patients With HAE
This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.
HAE is characterized by recurrent localized angioedema caused by uncontrolled activation of
the complement and contact systems due to a congenital deficiency of functional C1
inhibitor.
rhC1INH has been developed to offer a more widely available therapeutic alternative to the
existing plasma-derived C1INH (pdC1INH) products that have been used in the treatment of
acute angioedema attacks patients with HAE.
Patients who have qualified for enrollment in advance and who present to a study center
within 5 hours of onset of an attack will be evaluated for eligibility. 75 eligible patients
will be randomized (3:2) to receive an intravenous infusion of rhC1INH or saline in a
double-blind fashion. Open-label rhC1INH may be provided as rescue medication to patients
who do not experience the beginning of relief within 4 hours or who experience
life-threatening oropharyngeal-laryngeal angioedema symptoms.
Any patient having received a randomized treatment will be allowed to receive treatment with
rhC1INH in an open-label fashion for subsequent eligible attacks.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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