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Safety and Efficacy Study of Repeated Doses of DX-88 (Ecallantide) to Treat Attacks of Hereditary Angioedema (HAE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00456508
Recruitment Status : Completed
First Posted : April 5, 2007
Results First Posted : December 28, 2012
Last Update Posted : February 20, 2018
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of repeated doses of ecallantide in the treatment of acute attacks of hereditary angioedema and to allow HAE patients continued access to ecallantide. In addition, patients enrolled in DX-88/20 (EDEMA4) trial will be followed up and treated for subsequent attacks in this trial.

Condition or disease Intervention/treatment Phase
Hereditary Angioedema (HAE) Drug: ecallantide Phase 3

Detailed Description:

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 147 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks
Study Start Date : April 1, 2007
Actual Primary Completion Date : June 1, 2010
Actual Study Completion Date : September 1, 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Ecallantide

Arm Intervention/treatment
Experimental: DX-88 (ecallantide)
DX-88 (ecallantide) Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
Drug: ecallantide
solution for SC injection, one 30 mg dose per HAE attack
Other Name: DX-88




Primary Outcome Measures :
  1. Change From Baseline in Mean Symptom Complex Severity (MSCS) Score at 4 Hrs Post Dosing [ Time Frame: 4 hrs post dose after every episode ]
    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.


Secondary Outcome Measures :
  1. Treatment Outcome Score (TOS) at 4 Hrs Post Dosing, Based on the Patient Assessment of Baseline Severity of Symptoms [ Time Frame: 4 hrs post dose after every episode ]
    The Treatment Outcome Score (TOS)is a validated measure of response to therapy. Response assessment for each symptom complex (internal head/neck, stomach/GI, genital/buttocks, external head/neck or cutaneous) was to be weighted based on the severity of symptom complexes at baseline. Severity assessment at baseline was rated on a categorical scale (1=mild, 2=moderate, 3=severe) for symptoms at each affected symptom complex. Response assessment of each symptom complex post-dosing relative to baseline used a scale (100=significant improvement, 50=improvement, 0=same). The weighted values were used to calculate the composite TOS. A TOS greater than 0 denotes an improvement in symptoms compared with baseline severity.

  2. Time to Significant Improvement [ Time Frame: 15 min - 4 hrs post dose after every episode ]
    Time to significant improvement in overall response based on the period from 15 minutes after dosing through 4 hrs post dosing. Significant improvement was defined as a response of "a lot better or resolved" in the overall response assessment.



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Ages Eligible for Study:   10 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 offered

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00456508


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Locations
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United States, Arizona
Aaron Davis
Scottsdale, Arizona, United States, 85251
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Little Rock Allergy & Asthma Clinic
Little Rock, Arkansas, United States, 72205
United States, California
Alta Bates Summit Comprehensive Cancer Center
Berkeley, California, United States, 94704
Pacific Coast Allergy
Crescent City, California, United States, 95531
Jacob Offenberger
Granada Hills, California, United States, 91344
UCLA David Geffen School of Medicine, Department of Medicine
Los Angeles, California, United States, 90095-1680
United States, Colorado
Asthma and Allergy Associates, P.C.
Colorado Springs, Colorado, United States, 80907
United States, Delaware
Christiana Hospital, Christiana Care Health Services
Newark, Delaware, United States, 19718
United States, District of Columbia
Georgetown University Medical Center, Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
University of Miami, General Clinical Research Center
Miami, Florida, United States, 33136
University of South Florida, Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States, 33613
Roberson Allergy and Asthma
West Palm Beach, Florida, United States, 33401
United States, Georgia
Family Allergy & Asthma Center, PC
Atlanta, Georgia, United States, 30342
Allergy Center of Brookstone
Columbus, Georgia, United States, 31904
United States, Illinois
University Consultants in Allergy and Immunology
Chicago, Illinois, United States, 60612
United States, Indiana
Muncie Allergy Center
Muncie, Indiana, United States, 47304
United States, Kansas
Kansas City Allergy & Asthma
Overland Park, Kansas, United States, 66210
United States, Maryland
Institute for Asthma and Allergy
Wheaton, Maryland, United States, 20902
United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
United States, Michigan
Asthma and Allergy Institutes of Michigan
Clinton Township, Michigan, United States, 48038
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States, 48197
United States, Nevada
Nevada Access to Research and Education Society
Las Vegas, Nevada, United States, 89102
University of Nevada School of Medicine
Reno, Nevada, United States, 89503
United States, New Jersey
UMDNJ- New Jersey Medical School
Newark, New Jersey, United States, 07103
United States, New Mexico
Allergy Partners of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
United States, North Carolina
Allergy Partners of Western North Carolina
Asheville, North Carolina, United States, 28801
United States, Ohio
University of Cincinnati, Division of Internal Medicine
Cincinnati, Ohio, United States, 45267
Optimed Research, LLC
Columbus, Ohio, United States, 43235
United States, Pennsylvania
Penn State Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Asthma Allergy and Pulmonary Associates
Philadelphia, Pennsylvania, United States, 19107
Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Tennessee
Highlands Allergy and Asthma Center, PC
Bristol, Tennessee, United States, 37620
United States, Texas
The Paull Allergy and Asthma Clinic, P.A
Bryan, Texas, United States, 77802
AARA Research Center
Dallas, Texas, United States, 75231
United States, Utah
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132-2409
United States, Virginia
Clinical Research Associates of Tidewater
Norfolk, Virginia, United States, 23507
United States, Washington
Puget Sound Allergy, Asthma, & Immunology
Tacoma, Washington, United States, 98405
Canada, Ontario
Allergy and Asthma Research Centre
Ottawa, Ontario, Canada, K1Y 4G2
Jordan
Jordan University Hospital
Amman, Jordan, 1194
Sponsors and Collaborators
Shire
Investigators
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Study Director: Bill Pullman, MD, PhD Dyax Corp.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00456508     History of Changes
Other Study ID Numbers: DX-88/19
First Posted: April 5, 2007    Key Record Dates
Results First Posted: December 28, 2012
Last Update Posted: February 20, 2018
Last Verified: January 2018
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn
Ecallantide
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents