C1 Esterase Inhibitor in Hereditary Angioedema (HAE) (Extension Study)

Active, not recruiting

• Conditions: Congenital C1-INH deficiency; MedDRA version: 17.1Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2005-003139-38-Outside-EU/EEA
• Lead Sponsor: ZLB Behring GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-12
• Last Update Posted: 16 February 2015

Recruitment & Eligibility

• Status: Active
• Sex: All
• Target Recruitment: 57

Inclusion Criteria

• Documented congenital C1-INH deficiency
• Acute HAE attack
• Participation in the pivotal study CE1145_3001 (NCT00168103)
Are the trial subjects under 18? yes
Number of subjects for this age range: 7
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 50
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Acquired angioedema
• Treatment with any other investigational drug besides CE1145 in the last 30 days before study entry

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified