Efficacy and Safety Study of DX-88 to Treat Hereditary Angioedema (HAE)

This study has been completed.

Sponsors and Collaborators:	Dyax Corporation Genzyme Dyax-Genzyme LLC
Information provided by:	Dyax Corporation
ClinicalTrials.gov Identifier:	NCT00262080

Purpose

The purpose of this study is to determine if a subcutaneous dose of DX-88 (an investigational product) is safe and relieves symptoms of HAE in patients suffering from moderate to severe attacks.

Condition	Intervention	Phase
Hereditary Angioedema (HAE)	Drug: DX-88	Phase III

Drug Information available for: Kallidinogenase Ecallantide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	A Double-Blind, Placebo-Controlled Study Followed by a Repeat Dosing Phase to Assess the Efficacy and Safety of DX-88 (Recombinant Plasma Kallikrein Inhibitor) for the Treatment of Acute Attacks of Hereditary Angioedema

Further study details as provided by Dyax Corporation:

Primary Outcome Measures:

Patient reported outcome of efficacy at 4 hours

Secondary Outcome Measures:

Change in symptom severity at 4 hours
Time to significant improvement

Estimated Study Completion Date:

September 2007

Eligibility

Ages Eligible for Study:	10 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Diagnosis and history of HAE
Age 10 and older
Willing and able to sign informed consent
Moderate or severe HAE attack at the time of presentation for dosing

Exclusion Criteria:

Acquired angioedema
Estrogen-dependent angioedema
Drug induced angioedema
Pregnancy or breastfeeding
Receipt of non-investigational C1-INH within 7 days of treatment
Receipt of investigational drug or device, other than DX-88, within 30 days of treatment

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262080

Locations

United States, Maryland
Institute for Asthma and Allergy
Wheaton, Maryland, United States, 20902

Sponsors and Collaborators

Dyax Corporation

Genzyme

Dyax-Genzyme LLC

More Information

Study ID Numbers:	EDEMA3 (DX-88/14)
Study First Received:	December 5, 2005
Last Updated:	October 26, 2007
ClinicalTrials.gov Identifier:	NCT00262080
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
Kallikreins
Genetic Diseases, Inborn
Skin Diseases
Angioedema

Hypersensitivity, Immediate
Vascular Diseases
Urticaria
Angioedema, Hereditary
Hereditary angioedema

Additional relevant MeSH terms:

Skin Diseases, Vascular
Immune System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009