Skip to main content
OpenTrials
Completed

NCT Number: NCT00292981

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

Hereditary angioedema (HAE) is a rare disorder characterized by congenital lack of functional C1 esterase inhibitor. If not treated adequately, the acute attacks of HAE can be life-threatening and may even result in fatalities, especially in case of involvement of the larynx.The planned extension study is designed to enrol subjects that participated in the pivotal study in order to provide them with C1-INH for treatment of acute HAE attacks for 24 months or until the licensing procedure for C1-INH is finalized, whatever comes first.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hereditary Angioedema Angioedema Angioedemas, Hereditary Cardiovascular Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hereditary Complement Deficiency Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Immunologic Deficiency Syndromes Primary Immunodeficiency Diseases Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Urticaria Vascular Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Contact CSL Behring for facility details, Ottawa, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Documented congenital C1-INH deficiency
  • Acute HAE attack
  • Participation in base study CE1145_3001 (NCT00168103)

Key Exclusion Criteria:

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

Treatment and study plan

C1 Esterase Inhibitor

Drug

Lyophilisate containing approximately 500 U C1-INH to be reconstituted with 10 mL water for injection; Single Dose: 20 U/kg b.w. iv

Other names: Berinert P

Primary outcomes

  1. Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)

    Time frame: Up to 24 h after start of study treatment

    The start of symptom relief was determined by subject self-assessment.

  2. Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)

    Time frame: Up to 24 h after start of study treatment

    The start of symptom relief was determined by subject self-assessment.

Secondary outcomes

  1. Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)

    Time frame: Up to Day 9 following an attack

    Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.

  2. Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)

    Time frame: Up to Day 9 following an attack

    Complete resolution of symptoms was determined by subject self-assessment and documented on a diary card.

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study title

Open-label Extension Study of CE1145 (Human Pasteurized C1 Esterase Inhibitor Concentrate) in Subjects With Congenital C1-INH Deficiency and Acute HAE Attacks

Important dates

Study start
2005
Primary completion
2010
Study completion
2010
First posted
Feb 16, 2006
Registry last updated
May 7, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.