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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
N/A
Not Enrolling
Both
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:

Interventional

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:

No

Principal Investigator

Patrick Horn, MD, PhD

Investigator Role:

Study Director

Investigator Affiliation:

Dyax Corp.

Authority:

United States: Food and Drug Administration

Study ID:

EDEMA4 (DX-88/20)

NCT ID:

NCT00457015

Start Date:

April 2007

Completion Date:

June 2008

Related Keywords:

  • Hereditary Angioedema
  • Angioedema
  • Angioedemas, Hereditary

Name

Location

Winthrop University HospitalMineola, New York  11501
Arkansas Children's HospitalLittle Rock, Arkansas  72202-3591
Brigham and Women's HospitalBoston, Massachusetts  02115
Alta Bates Comprehensive Cancer CenterBerkeley, California  94704
University of UtahSalt Lake City, Utah  
Georgetown University HospitalWashington, District of Columbia  20007
University of CincinnatiCincinnati, Ohio  45267-0502
Penn State Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
University of South FloridaTampa, Florida  33612
Christiana HospitalWilmington, Delaware  
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
University of Miami, General Clinical Research CenterMiami, Florida  33136
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
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
Allergy Partners of AlbuquerqueAlbuquerque, New Mexico  87109
Allergy Partners of Western North CarolinaAsheville, North Carolina  28801
Optimed Research, LLCColumbus, Ohio  43235
Asthma Allergy and Pulmonary AssociatesPhiladelphia, Pennsylvania  19107
Highlands Allergy and Asthma Center, PCBristol, Tennessee  37620
AARA Research CenterDallas, Texas  75231
Clinical Research Associates of TidewaterNorfolk, Virginia  23507
Puget Sound Allergy, Asthma, & ImmunologyTacoma, Washington  98405
Aaron J. DavisScottsdale, Arizona  85251
Asthma and Allergy Institute of MichiganClinton TWP, Michigan  48038
UMDNJ-New Jersey Medical SchoolNewark, New Jersey  07103
Valley Clinical Research CenterEaston, Pennsylvania  18045
Childrens Hospital of PittsburghPittsburgh, Pennsylvania  15213
The Paull Allergy and Asthma Clinic, P.A.Bryan, Texas  77802
University of Texas Medical SchoolGalveston, Texas  77555-1083
Baylor Clinic, Baylor College of MedicineHouston, Texas  77030