A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

Hereditary Angioedema Types I and II Clinical Trial

Official title:
A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Clinical Efficacy and Safety of Subcutaneous Administration of Human Plasma-derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema

Status Completed

Clinical Trial Summary

The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema. The safety of C1-esterase inhibitor will also be assessed. Each subject will enter a run-in period of up to 8-weeks. Subjects who complete the run-in period and who are eligible will then enter the treatment phase which comprises two sequential treatment periods. In the treatment phase, subjects will be randomized to one of four arms consisting of treatment with low- or higher-volume C1-esterase inhibitor in one treatment period and treatment with low- or higher-volume placebo in the other treatment period. The study will measure the number of hereditary angioedema attacks that subjects experience while receiving each treatment.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Angioedema
Hereditary Angioedema Types I and II

Clinical Trial Details

NCT number	NCT01912456
Study type	Interventional
Source	CSL Behring
Contact
Status	Completed
Phase	Phase 3
Start date	January 2014
Completion date	October 2015

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT01760343` - A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor	Phase 1
Completed	`NCT04618211` - Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema	Phase 2
Recruiting	`NCT06343779` - Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema	Phase 3
Completed	`NCT02316353` - A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema	Phase 3
Recruiting	`NCT05396105` - Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema	Phase 2/Phase 3
Withdrawn	`NCT01832896` - Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema	Phase 2
Completed	`NCT01576523` - A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route	Phase 1/Phase 2
Active, not recruiting	`NCT05047185` - Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II	Phase 2