Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
This study is ongoing, but not recruiting participants.
Sponsor:
Dyax Corp.
Information provided by (Responsible Party):
Dyax Corp.
ClinicalTrials.gov Identifier:
NCT01059526
First received: January 28, 2010
Last updated: April 3, 2013
Last verified: April 2013
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Purpose
The objective of this study is to evaluate the formation of antibodies, the occurence of allergic reactions, and the risk of hypercoagulability and hypocoagulability in patients treated with KALBITOR (ecallantide).
| Condition | Intervention |
|---|---|
|
Hereditary Angioedema |
Drug: ecallantide |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A Phase 4, Long-Term Observational Safety Study to Evaluate Immunogenicity and Hypersensitivity With Exposure to KALBITOR (Ecallantide) for the Treatment of Acute Attacks of HAE |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary angioedema
MedlinePlus related topics:
Allergy
Drug Information available for:
Ecallantide
U.S. FDA Resources
Further study details as provided by Dyax Corp.:
Primary Outcome Measures:
- Occurence of anaphylaxis or other adverse events suggestive of hypersensitivity [ Time Frame: 12 months after first treatment ] [ Designated as safety issue: Yes ]
- Occurence of seroconversion to anti-ecallantide antibodies upon exposure to KALBITOR. [ Time Frame: 12 months after first treatment ] [ Designated as safety issue: Yes ]
- Occurence of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to KALBITOR [ Time Frame: 12 months after first treatment ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Overall Patient Response Assessment [ Time Frame: 90 minutes post-dose ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
serum
| Estimated Enrollment: | 200 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | February 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Patients naive to KALBITOR
HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
|
Drug: ecallantide
30 mg SC
Other Name: Kalbitor
|
|
Patients non- naive to KALBITOR
HAE patients that have been treated with KALBITOR prior to enrollment in the study
|
Drug: ecallantide
30 mg SC
Other Name: Kalbitor
|
Detailed Description:
The objective of this study is to evaluate immunogenicity and hypersensitivity upon exposure to KALBITOR, in particular:
- Determine the rate of anaphylaxis and Type I hypersensitivity reactions upon exposure to KALBITOR.
- Determine the rate of seroconversion to anti-ecallantide antibodies upon exposure to KALBITOR.
- Determine the rate of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to KALBITOR.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with hereditary angioedema, either naive or non-naive to KALBITOR (ecallantide)
Criteria
Inclusion Criteria:
- Patients indicated per the approved product label for KALBITOR
- Patient or guardian is able to understand and sign the informed consent form
- Patient is willing and able to undergo a skin test procedure at screening (baseline)
Exclusion Criteria:
- Patient contraindicated per the approved product label for KALBITOR
- Patient confirmed pregnancy or active breastfeeding
- Any other condition that, in the opinion of the Investigator, may compromise the safety or compliance of the patient or would preclude the patient from successful completion of the study
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01059526
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Hide Study LocationsLocations
| United States, Arkansas | |
| Little Rock Allergry and Asthma Clinical Research Center | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Sunrise Clinical Research | |
| Bell Gardens, California, United States, 90201 | |
| Allergy & Asthma Institute of the Valley | |
| Granada Hills, California, United States, 91344 | |
| Unidversity of California, Los Angeles David Geffen School of Medicine | |
| Los Angeles, California, United States, 90095-1680 | |
| 705 West LaVeta | |
| Orange, California, United States, 92868 | |
| Allergy & Asthma Clinical Research Inc. | |
| Walnut Creek, California, United States, 94598 | |
| United States, Connecticut | |
| Center for Allergy, Asthma & Immunology | |
| Waterbury, Connecticut, United States, 06708 | |
| United States, Florida | |
| University of South Florida Asthma | |
| Tampa, Florida, United States, 33613 | |
| United States, Georgia | |
| Brookstone Clinical Research Center | |
| Columbus, Georgia, United States, 31904 | |
| United States, Illinois | |
| University Consultants in Allergry and Immunology | |
| Chicago, Illinois, United States, 60612 | |
| United States, Indiana | |
| Deaconess Clinic Downtown | |
| Evansville, Indiana, United States, 47713 | |
| Muncie Allergy Ctr | |
| Muncie, Indiana, United States, 47304 | |
| United States, Kansas | |
| Kansas City Allergy and Asthma Associates | |
| Overland Park, Kansas, United States, 66210 | |
| United States, Louisiana | |
| Ochsner Health System - Allergy, Asthma and Immunology Department | |
| Jefferson, Louisiana, United States, 70121 | |
| Clinical Research Specialists | |
| Metairie, Louisiana, United States, 70006 | |
| United States, Maryland | |
| Institute for Asthma and Allergy, P.C. | |
| Chevy Chase, Maryland, United States, 20815 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Chestnut Hill, Massachusetts, United States, 02467 | |
| United States, Michigan | |
| University of Michigan Health System Allergy Specialty Clinic | |
| Ann Arbor, Michigan, United States, 48105 | |
| Asthma and Allergy Institute of Michigan | |
| Clinton Township, Michigan, United States, 48038 | |
| United States, Missouri | |
| Saint Louis University School of Medicine | |
| St. Louis, Missouri, United States, 63104 | |
| Washington University School of Medicine | |
| St. Louis, Missouri, United States, 63110 | |
| United States, Nevada | |
| University of Nevada School of Medicine - Department of Pediatrics | |
| Reno, Nevada, United States, 89503 | |
| United States, New Jersey | |
| Allergy Treatment Center of New Jersey | |
| Iselin, New Jersey, United States, 08830 | |
| United States, New York | |
| Bronx, New York, United States, 10465 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| Medical Research Associates of CNY | |
| North Syracuse, New York, United States, 13212 | |
| United States, North Carolina | |
| Allergy Partners of Western North Carolina | |
| Ashville, North Carolina, United States, 28801 | |
| Specialty Medical Clinic And Research Center | |
| Sanford, North Carolina, United States, 27330 | |
| United States, Ohio | |
| Department of Internal Medicine, University of Cincinnati -MSB | |
| Cincinnati, Ohio, United States, 45267-0563 | |
| Optimed Research, LTD | |
| Columbus, Ohio, United States, 43235 | |
| Reynolds Clinic | |
| Toledo, Ohio, United States, 43615 | |
| Toledo Institute of Clinical Research | |
| Toledo, Ohio, United States, 43617 | |
| United States, Oklahoma | |
| Allergy Clinic of the Tulsa, Inc. | |
| Tulsa, Oklahoma, United States, 74133 | |
| United States, Pennsylvania | |
| Penn State University - Penn State Milton S. Hershey Medical Center | |
| Hershey, Pennsylvania, United States, 17033-0850 | |
| Children's Hospital of Pittsburgh of UPMC | |
| Pittsburgh, Pennsylvania, United States, 15224 | |
| United States, Texas | |
| AARA Research Center | |
| Dallas, Texas, United States, 75231 | |
| United States, Utah | |
| University of Utah, Department of Dermatology | |
| Salt Lake City, Utah, United States, 84132 | |
| United States, Virginia | |
| Children's Hospital of the King's Daughters | |
| Norfolk, Virginia, United States, 23507 | |
| Virginia Beach, Virginia, United States, 23452 | |
| United States, Washington | |
| Puget Sound Allergy, Asthma and Immunology | |
| Tacoma, Washington, United States, 98405 | |
Sponsors and Collaborators
Dyax Corp.
Investigators
| Study Director: | Yung Chyung, MD | Dyax Corp. |
More Information
No publications provided
| Responsible Party: | Dyax Corp. |
| ClinicalTrials.gov Identifier: | NCT01059526 History of Changes |
| Other Study ID Numbers: | DX-88/24 |
| Study First Received: | January 28, 2010 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Dyax Corp.:
|
HAE |
Additional relevant MeSH terms:
|
Angioedema Angioedemas, Hereditary Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular |
Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on June 17, 2013