At a glance
ClinicalIndex Comparison Record- ✓Documented congenital C1-INH deficiency
- ✓Acute facial or abdominal HAE attack
- ✕Acquired angioedema
- ✕Treatment with any other investigational drug within the last 30 days before study entry
- ✕Treatment with any C1-INH concentrate within the previous 7 days
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Human Pasteurized C1 Esterase Inhibitor Concentrate (CE1145) in Subjects With Congenital C1-INH Deficiency and Acute Abdominal or Facial HAE Attacks
In Brief
A Phase 3 clinical trial evaluating C1 Esterase Inhibitor and Placebo for Hereditary Angioedema. Completed, enrolled 126 participants across 36 sites in 15 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
Single application of C1-INH administered intravenously by slow injection or infusion at a recommended rate of 4mL/min.
Single application of physiological saline solution equivalent to the volume calculated for subjects in the C1-INH 20 U/kg bw arm.