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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing

Outcome Description:

Mean Symptom Complex Severity (MSCS) score is a validated point-in-time measure of symptom severity. At baseline and 4 hrs, patients rated the severity on a categorical scale (0=normal, 1=mild, 2=moderate, 3=severe) for symptoms at each affected anatomical location. Ratings were averaged to obtain the MSCS score. A decrease in MSCS score reflected an improvement in symptoms; clinically meaningful improvement was indicated by a reduction in the score of 0.30 or more.

Outcome Time Frame:

4 hrs post dose after every episode

Safety Issue:

No

Principal Investigator

Bill Pullman, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Dyax Corp.

Authority:

United States: Food and Drug Administration

Study ID:

DX-88/19

NCT ID:

NCT00456508

Start Date:

April 2007

Completion Date:

September 2010

Related Keywords:

• Hereditary Angioedema
• Angioedema
• Angioedemas, Hereditary