Know Cancer

forgot password

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



University of Utah Health Sciences CenterSalt Lake City, Utah  84132
Children's Hospital of PittsburghPittsburgh, Pennsylvania  15213
Winthrop University HospitalMineola, New York  11501
Arkansas Children's HospitalLittle Rock, Arkansas  72202-3591
Brigham and Women's HospitalBoston, Massachusetts  02115
Alta Bates Summit Comprehensive Cancer CenterBerkeley, California  94704
Penn State Milton S Hershey Medical CenterHershey, Pennsylvania  17033
Aaron DavisScottsdale, Arizona  85251
Little Rock Allergy & Asthma ClinicLittle Rock, Arkansas  72205
Pacific Coast AllergyCrescent City, California  95531
Jacob OffenbergerGranada Hills, California  91344
UCLA David Geffen School of Medicine, Department of MedicineLos Angeles, California  90095-1680
Asthma and Allergy Associates, P.C.Colorado Springs, Colorado  80907
Christiana Hospital, Christiana Care Health ServicesNewark, Delaware  19718
Georgetown University Medical Center, Georgetown University HospitalWashington, District of Columbia  20007
University of Miami, General Clinical Research CenterMiami, Florida  33136
University of South Florida, Asthma, Allergy and Immunology Clinical Research UnitTampa, Florida  33613
Roberson Allergy and AsthmaWest Palm Beach, Florida  33401
Family Allergy & Asthma Center, PCAtlanta, Georgia  30342
Allergy Center of BrookstoneColumbus, Georgia  31904
University Consultants in Allergy and ImmunologyChicago, Illinois  60612
Muncie Allergy CenterMuncie, Indiana  47304
Kansas City Allergy & AsthmaOverland Park, Kansas  66210
Institute for Asthma and AllergyWheaton, Maryland  20902
Asthma and Allergy Institutes of MichiganClinton TWP, Michigan  48038
Respiratory Medicine Research Institute of Michigan, PLCYpsilanti, Michigan  48197
Nevada Access to Research and Education SocietyLas Vegas, Nevada  89102
University of Nevada School of MedicineReno, Nevada  89503
UMDNJ- New Jersey Medical SchoolNewark, New Jersey  07103
Allergy Partners of AlbuquerqueAlbuquerque, New Mexico  87109
Allergy Partners of Western North CarolinaAsheville, North Carolina  28801
University of Cincinnati, Division of Internal MedicineCincinnati, Ohio  45267
Optimed Research, LLCColumbus, Ohio  43235
Asthma Allergy and Pulmonary AssociatesPhiladelphia, Pennsylvania  19107
Highlands Allergy and Asthma Center, PCBristol, Tennessee  37620
The Paull Allergy and Asthma Clinic, P.ABryan, Texas  77802
AARA Research CenterDallas, Texas  75231
Clinical Research Associates of TidewaterNorfolk, Virginia  23507
Puget Sound Allergy, Asthma, & ImmunologyTacoma, Washington  98405