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

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

April 4, 2007

Last Updated Date

January 7, 2009

Start Date ^†

April 2007

Current Primary Outcome Measures ^†

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

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00456508 on ClinicalTrials.gov Archive Site

Current 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 ]

Original Secondary Outcome Measures ^†

Patient reported symptom change
Time to improvement

Descriptive Information

Brief Title ^†

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

Official Title ^†

Open-Label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks

Brief Summary

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.

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.

Study Phase

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^†

Hereditary Angioedema

Intervention ^†

Drug: ecallantide

Study Arms / Comparison Groups

Experimental: DX-88 (ecallantide)

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Estimated Enrollment ^†

150

Estimated Completion Date

December 2009

Estimated Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

10 Years and older

Accepts Healthy Volunteers

Contacts ^††

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

Location Countries ^†

United States, Canada, Jordan

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00456508

Responsible Party

Bill Pullman, MD, PhD, Executive Vice President, Chief Development Officer, Dyax Corp.

Secondary IDs ^††

Study Sponsor ^†

Dyax Corporation

Collaborators ^††

Investigators ^†

Study Director:

Patrick Horn, MD, PhD

Dyax Corp.

Information Provided By

Dyax Corporation

Verification Date

January 2009

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.