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| Sponsored by: |
Dyax Corporation |
|---|---|
| Information provided by: | Dyax Corporation |
| ClinicalTrials.gov Identifier: | NCT00456508 |
Purpose
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 | Intervention |
|---|---|
|
Hereditary Angioedema |
Drug: ecallantide |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Open-Label Patient Continuation of DX-88 (Ecallantide) for Acute Hereditary Angioedema Attacks |
| Estimated Enrollment: | 150 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
DX-88 (ecallantide)
|
Drug: ecallantide
solution for SC injection, one 30 mg dose per HAE attack
|
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.
Eligibility| Ages Eligible for Study: | 10 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: EDEMA Administrator | 1-888-675-9575 | edemaadmin@dyax.com |
| Contact: EDEMA Administrator | 1-617-250-5501 |
Hide Study Locations| United States, Arizona | |
| Aaron Davis | Recruiting |
| Scottsdale, Arizona, United States, 85251 | |
| Contact: Aaron Davis | |
| United States, Arkansas | |
| Arkansas Children's Hospital | Recruiting |
| Little Rock, Arkansas, United States, 72202 | |
| Contact: Stacie Jones, MD | |
| Little Rock Allergy & Asthma Clinic | Recruiting |
| Little Rock, Arkansas, United States, 72205 | |
| Contact: Karl Sitz, MD | |
| United States, California | |
| Jacob Offenberger | Recruiting |
| Granada Hills, California, United States, 91344 | |
| Contact: Jacob Offenberger | |
| Pacific Coast Allergy | Recruiting |
| Crescent City, California, United States, 95531 | |
| Contact: Christopher Chang | |
| UCLA David Geffen School of Medicine, Department of Medicine | Recruiting |
| Los Angeles, California, United States, 90095-1680 | |
| Contact: Marc Riedl | |
| Alta Bates Summit Comprehensive Cancer Center | Recruiting |
| Berkeley, California, United States, 94704 | |
| Contact: Usha Sunkara | |
| United States, Colorado | |
| Asthma and Allergy Associates, P.C. | Recruiting |
| Colorado Springs, Colorado, United States, 80907 | |
| Contact: Daniel Soteres | |
| United States, Delaware | |
| Christiana Hospital, Christiana Care Health Services | Recruiting |
| Newark, Delaware, United States, 19718 | |
| Contact: Gregory Marcotte | |
| United States, District of Columbia | |
| Georgetown University Medical Center, Georgetown University Hospital | Recruiting |
| Washington, District of Columbia, United States, 20007 | |
| Contact: Aziza Shad | |
| United States, Florida | |
| Roberson Allergy and Asthma | Recruiting |
| West Palm Beach, Florida, United States, 33401 | |
| Contact: Clive Roberson | |
| University of Miami, General Clinical Research Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Gary Kleiner | |
| University of South Florida, Asthma, Allergy and Immunology Clinical Research Unit | Recruiting |
| Tampa, Florida, United States, 33613 | |
| Contact: Richard Lockey | |
| United States, Georgia | |
| Allergy Center of Brookstone | Recruiting |
| Columbus, Georgia, United States, 31904 | |
| Contact: Robert Chrzanowski, MD | |
| Family Allergy & Asthma Center, PC | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Robyn Levy, MD | |
| United States, Illinois | |
| University Consultants in Allergy and Immunology | Recruiting |
| Chicago, Illinois, United States, 60612 | |
| Contact: Mary Tobin | |
| United States, Indiana | |
| Muncie Allergy Center | Recruiting |
| Muncie, Indiana, United States, 47304 | |
| Contact: Sai Karlapudi, MD | |
| United States, Kansas | |
| Kansas City Allergy & Asthma | Recruiting |
| Overland Park, Kansas, United States, 66210 | |
| Contact: Mark Neustrom, DO | |
| United States, Maryland | |
| Institute for Asthma and Allergy | Recruiting |
| Wheaton, Maryland, United States, 20902 | |
| Contact: H. Henry Li, MD | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | Recruiting |
| Chestnut Hill, Massachusetts, United States, 02467 | |
| Contact: Albert Sheffer | |
| United States, Michigan | |
| Respiratory Medicine Research Institute of Michigan, PLC | Recruiting |
| Ypsilanti, Michigan, United States, 48197 | |
| Contact: Jeffrey G. Leflein | |
| Asthma and Allergy Institutes of Michigan | Recruiting |
| Clinton TWP, Michigan, United States, 48038 | |
| Contact: Jeffrey Bruner | |
| United States, Nevada | |
| Nevada Access to Research and Education Society | Recruiting |
| Las Vegas, Nevada, United States, 89102 | |
| Contact: Jim Christensen | |
| University of Nevada School of Medicine | Recruiting |
| Reno, Nevada, United States, 89503 | |
| Contact: Mary Beth Hogan | |
| United States, New Jersey | |
| UMDNJ- New Jersey Medical School | Recruiting |
| Newark, New Jersey, United States, 07103 | |
| Contact: Leonard Bielory | |
| United States, New Mexico | |
| Allergy Partners of Albuquerque | Recruiting |
| Albuquerque, New Mexico, United States, 87109 | |
| Contact: Michael Keslin | |
| United States, New York | |
| Winthrop University Hospital | Recruiting |
| Mineola, New York, United States, 11501 | |
| Contact: Mark Davis-Lorton, MD | |
| United States, North Carolina | |
| Allergy Partners of Western North Carolina | Recruiting |
| Asheville, North Carolina, United States, 28801 | |
| Contact: Donald Russell, MD | |
| Contact: William McCann, MD | |
| United States, Ohio | |
| Optimed Research, LLC | Recruiting |
| Columbus, Ohio, United States, 43235 | |
| Contact: Donald McNeil, MD | |
| University of Cincinnati, Division of Internal Medicine | Recruiting |
| Cincinnati, Ohio, United States, 45267 | |
| Contact: Jonathan Bernstein | |
| United States, Pennsylvania | |
| Valley Clinical Research Center | Recruiting |
| Easton, Pennsylvania, United States, 18045 | |
| Contact: Eric Schenkel, MD | |
| Penn State Milton S Hershey Medical Center | Recruiting |
| Hershey, Pennsylvania, United States, 17033 | |
| Contact: Timothy Craig | |
| Asthma Allergy and Pulmonary Associates | Recruiting |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Contact: John Cohn | |
| Children's Hospital of Pittsburgh | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Contact: Andrew MacGinnitie | |
| United States, Tennessee | |
| Highlands Allergy and Asthma Center, PC | Recruiting |
| Bristol, Tennessee, United States, 37620 | |
| Contact: Neil Wallen, MD | |
| United States, Texas | |
| AARA Research Center | Recruiting |
| Dallas, Texas, United States, 75231 | |
| Contact: William Lumry, MD | |
| The Paull Allergy and Asthma Clinic, P.A | Recruiting |
| Bryan, Texas, United States, 77802 | |
| Contact: Keith Paull | |
| University of Texas Medical Branch | Recruiting |
| Galveston, Texas, United States, 77555-1083 | |
| Contact: J. Andrew Grant | |
| Baylor Clinic, Baylor College of Medicine | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: David Huston | |
| United States, Utah | |
| University of Utah Health Sciences Center | Recruiting |
| Salt Lake City, Utah, United States, 84132-2409 | |
| Contact: Gerald Gleich | |
| United States, Virginia | |
| Clinical Research Associates of Tidewater | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Duane G. Wombolt | |
| United States, Washington | |
| Puget Sound Allergy, Asthma, & Immunology | Recruiting |
| Tacoma, Washington, United States, 98405 | |
| Contact: Arthur Vegh, MD | |
| Canada, Ontario | |
| Allergy and Asthma Research Centre | Recruiting |
| Ottawa, Ontario, Canada, K1Y 4G2 | |
| Contact: William Yang | |
| University of Toronta | Recruiting |
| Toronto, Ontario, Canada, M4V 1R2 | |
| Contact: Gordon Sussman | |
| Jordan | |
| Jordan University Hospital | Recruiting |
| Amman, Jordan, 1194 | |
| Contact: Mustafa Shennak | |
| Study Director: | Patrick Horn, MD, PhD | Dyax Corp. |
More Information
| Responsible Party: | Dyax Corp. ( Bill Pullman, MD, PhD, Executive Vice President, Chief Development Officer ) |
| Study ID Numbers: | DX-88/19 |
| Study First Received: | April 4, 2007 |
| Last Updated: | January 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00456508 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Hereditary Angioedema Hypersensitivity Genetic Diseases, Inborn Skin Diseases Angioedema |
Hypersensitivity, Immediate Vascular Diseases Urticaria Angioedema, Hereditary |
|
Hypersensitivity Skin Diseases, Vascular Genetic Diseases, Inborn Immune System Diseases Skin Diseases Angioedema |
Hypersensitivity, Immediate Vascular Diseases Urticaria Cardiovascular Diseases Angioedema, Hereditary |
