Human C1 Esterase Inhibitor in Subjects With Congenital C1-INH Deficiency and Acute Abdominal and Facial HAE Attacks - Full Text View

Sponsored by:	CSL Behring
Information provided by:	CSL Behring
ClinicalTrials.gov Identifier:	NCT00168103

Purpose

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 clinical Phase II/III study is designed to provide clinically relevant data on dosing, efficacy and safety in HAE subjects.

Condition	Intervention	Phase
Hereditary Angioedema	Drug: C1 Esterase Inhibitor	Phase II Phase III

Drug Information available for: C1 esterase inhibitor

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Human Pasteurized C1 Esterase Inhibitor Concentrate (CE1145) in Subjects With Congenital C1-INH Deficiency and Acute Abdominal or Facial HAE Attacks

Further study details as provided by CSL Behring:

Primary Outcome Measures:

Relief of symptoms from hereditary angioedema (HAE) attacks

Secondary Outcome Measures:

Proportion of subjects with increased intensity of clinical HAE symptoms between 2 and 4 h after start of study drug administration
Number of vomiting episodes within 4 h after start of study treatment

Estimated Enrollment:	90
Study Start Date:	June 2005
Study Completion Date:	October 2007

Eligibility

Ages Eligible for Study:	6 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Documented congenital C1-INH deficiency
Acute facial or abdominal HAE attack

Key Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00168103

Locations

United States, Georgia

Atlanta, Georgia, United States, 30342

Sponsors and Collaborators

CSL Behring

More Information

Click here for more information about the study. This link exits the ClinicalTrials.gov site

Study ID Numbers:	CE1145_3001
Study First Received:	September 12, 2005
Last Updated:	January 30, 2008
ClinicalTrials.gov Identifier:	NCT00168103
Health Authority:	United States: Food and Drug Administration

Keywords provided by CSL Behring:

C1 Inhibitor
Hereditary angioedema
Acute HAE attack

Study placed in the following topic categories:

Hypersensitivity
Genetic Diseases, Inborn
Skin Diseases
Facies
Angioedema
Hypersensitivity, Immediate

Vascular Diseases
Urticaria
Angioedema, Hereditary
Hereditary angioedema
Complement C1 Inhibitor Protein
Complement C1s

Additional relevant MeSH terms:

Skin Diseases, Vascular
Immunologic Factors
Immune System Diseases
Physiological Effects of Drugs

Cardiovascular Diseases
Immunosuppressive Agents
Complement Inactivating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 13, 2009