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

Phase 3
10 Years
Not Enrolling
Hereditary Angioedema

Thank you

Trial Information

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

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.

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

Type of Study:


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:


Principal Investigator

Bill Pullman, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Dyax Corp.


United States: Food and Drug Administration

Study ID:




Start Date:

April 2007

Completion Date:

September 2010

Related Keywords:

  • Hereditary Angioedema
  • Angioedema
  • Angioedemas, Hereditary



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