Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE) - Full Text View

Sponsored by:	Dyax Corporation
Information provided by:	Dyax Corporation
ClinicalTrials.gov Identifier:	NCT00456508

Purpose

The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Condition	Intervention
Hereditary Angioedema	Drug: ecallantide

MedlinePlus related topics: Edema

Drug Information available for: Ecallantide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Open-Label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks

Further study details as provided by Dyax Corporation:

Primary Outcome Measures:

Change in symptom severity as reported by the patient [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient reported symptom change [ Time Frame: 4 hours ] [ Designated as safety issue: No ]
Time to improvement [ Time Frame: 4 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	150
Study Start Date:	April 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental DX-88 (ecallantide)	Drug: ecallantide solution for SC injection, one 30 mg dose per HAE attack

Detailed Description:

This is an open label trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide in the treatment of acute attacks of hereditary angioedema. This study is designed to provide efficacy and safety data on repeated use of ecallantide. These data are intended to support the marketing authorization of ecallantide in the treatment of acute attacks of hereditary angioedema. Efficacy and safety of ecallantide will be evaluated in this study.

Eligibility

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

Criteria

Inclusion Criteria:

10 years of age or older
Documented diagnosis of HAE (Type I or II)
Willing and able to give informed consent
Acute HAE attack at time of presentation

Exclusion Criteria:

Receipt of an investigational drug or device, within 30 days prior to study treatment, other than DX-88 (ecallantide)
Pregnancy or breastfeeding
Receipt of non-investigational C1-INH or DX-88 within 72 hours of treatment
Patients eligible for current, ongoing clinical trial in which DX 88 (ecallantide) is offered

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00456508

Contacts

Contact: EDEMA Administrator	1-888-675-9575	edemaadmin@dyax.com
Contact: EDEMA Administrator	1-617-250-5501

Show 45 Study Locations

Sponsors and Collaborators

Dyax Corporation

Investigators

Study Director:

Patrick Horn, MD, PhD

Dyax Corp.

More Information

Responsible Party:	Dyax Corp. ( Bill Pullman, MD, PhD, Executive Vice President, Chief Development Officer )
Study ID Numbers:	DX-88/19
Study First Received:	April 4, 2007
Last Updated:	January 7, 2009
ClinicalTrials.gov Identifier:	NCT00456508
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Hypersensitivity
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