Hereditary Angioedema Clinical Trial
Official title:
Human Pasteurized C1 Esterase Inhibitor Concentrate (CE1145) in Subjects With Congenital C1-INH Deficiency and Acute Abdominal or Facial HAE Attacks
HAE is a rare disorder characterized by functional C1 esterase inhibitor deficiency. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of swelling of the larynx. This clinical Phase 2/Phase 3 study was designed to provide clinically relevant data on dosing, efficacy and safety in subjects with HAE.
For each subject, only a single abdominal or facial attack was treated and evaluated. After
receiving treatment, subjects were observed for a minimum of 4 hours, after which they could
be discharged from the study center if they reported onset of symptom relief. Starting from
4 hours after treatment, subjects who reported insufficient or no symptom relief could
receive a second dose of double-blind treatment (called "rescue medication") as follows:
C1-INH 20 U/kg bw for subjects initially receiving placebo, C1-INH 10 U/kg bw for subjects
initially receiving C1-INH 10 U/kg bw, and placebo for subjects initially receiving C1-INH
20 U/kg bw.
The study was defined to be successful if the primary outcome measure and at least one of
the secondary outcome measures were met in the comparison between the C1-INH 20 U/kg bw
group and the Placebo group.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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