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EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of DX-88 (Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema

Phase 3
10 Years
Not Enrolling
Hereditary Angioedema

Thank you

Trial Information

EDEMA4: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of DX-88 (Ecallantide) for the Treatment of Acute Attacks of Hereditary Angioedema

This is a randomized placebo-controlled trial.

The study is designed to assess the efficacy and safety of 30 mg subcutaneous ecallantide
versus placebo in the treatment of moderate to severe acute attacks of hereditary
angioedema. This study is conducted under Special Protocol Assessment with the FDA and is
designed to provide pivotal efficacy data on 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

- Executed informed consent

- Documented diagnosis of HAE (Type I or II)

- Presentation at the site within 8 hours of patient recognition of an moderate to
severe HAE acute attack

Exclusion Criteria:

- Receipt of an investigational drug or device, within 30 days prior to study treatment

- Receipt of non-investigational C1-INH within 7 days of treatment

- Receipt of DX-88 (ecallantide) within 3 days prior to study treatment

- Diagnosis of acquired angioedema (AAE), estrogen-dependent angioedema or drug-induced
angioedema (including angiotensin-converting enzyme inhibitor induced angioedema)

- Pregnancy or breastfeeding

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hours Post-dose

Outcome Description:

The Mean Symptom Complex Severity (MSCS) score is a validated, comprehensive point-in-time measure of symptom severity. At baseline and 4 hours, 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:

baseline, 4 hours post-dose

Safety Issue:


Principal Investigator

Patrick Horn, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Dyax Corp.


United States: Food and Drug Administration

Study ID:

EDEMA4 (DX-88/20)



Start Date:

April 2007

Completion Date:

June 2008

Related Keywords:

  • Hereditary Angioedema
  • Angioedema
  • Angioedemas, Hereditary



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