Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

Status:	Completed
Conditions:	Skin and Soft Tissue Infections
Therapuetic Areas:	Dermatology / Plastic Surgery
Healthy:	No
Age Range:	12 - Any
Updated:	11/30/2018
Start Date:	November 1, 2015
End Date:	July 24, 2017

A Phase 3, Randomized, Double-blind, Placebo-controlled, Two-period, Three-sequence, Partial Crossover Study to Evaluate the Efficacy and Safety of Subcutaneous Administration of 2000 IU of C1 Esterase Inhibitor [Human] Liquid for Injection for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

The purpose of this study is to assess the efficacy and safety of subcutaneous administration
of a liquid formulation of C1 esterase inhibitor for the prevention of angioedema attacks in
adolescent and adult subjects with hereditary angioedema.

The maximum duration of participation is approximately 9 months. Patients will complete a
screening period of up to 21 days. Following screening, eligible patients will be randomly
assigned to 1 of 3 treatment sequences. Each patient will undergo 2 14-week treatment
periods for a total of 28 weeks (Treatment Period 1 and Treatment Period 2). After
completing the 2 treatment periods, patients will enter a 1-month follow-up period.

We found this trial at

sites

Bernstein Clinical Research Center

Cincinnati, Ohio 45231

Phone: 513-354-1746

from 43215

Cincinnati, OH