Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
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
1 other identifier
observational
81
1 country
40
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2010
Longer than P75 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2010
CompletedFirst Posted
Study publicly available on registry
February 1, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedResults Posted
Study results publicly available
October 6, 2014
CompletedJune 8, 2021
May 1, 2021
3.6 years
January 28, 2010
September 10, 2014
May 14, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity
Based on medical review of multiple preferred terms for treatment emergent adverse events (TEAEs) suggestive of Type 1 hypersensitivity; terms included adverse drug reaction, anaphylaxis, anaphylactic reaction, anaphylactoid reaction, hypersensitivity, erythema, flushing, hot flush, pharyngeal edema, laryngeal edema, pruritus, pruritus generalized, rash, rash erythematous, rhinitis allergic, rhinorrhea, throat irritation, urticaria, urticaria localized, dyspnea, and wheezing. Records of patients with any of these TEAE referred terms were reviewed further to assess potential hypersensitivity reactions, considering factors such as timing of TEAEs in relationship to dose (ie, occurred within 24 hours after start of KALBITOR treatment), accompanying symptoms, Investigator causality assessment (ie, reported as possibly, probably, or definitely related to study drug), and any other available clinical information. Anaphylaxis subset determined based on criteria established by the NIAID.
12 months after first treatment
Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.
Seroconversion is the development of detectable specific antibodies in the blood serum. Serum was tested for development of antibodies (irrespective of immunoglobulin class) against ecallantide at screening and at all safety evaluations. Positive results were to undergo a confirmatory test. Confirmed positive samples were further titered. Patients who developed an antibody response were evaluated for the development of neutralizing antibodies. Patients also had their serum analyzed for IgE-specific antibodies to ecallantide at screening and during safety evaluations. Positive results underwent a confirmatory test. Confirmed positive samples were further titered.
12 months after first treatment
Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR
Events of ecchymosis, hemorrhage, petechiae, spontaneous hemorrhage, hematoma, gastrointestinal bleeding, hemorrhagic stroke and any other term indicative of a bleeding event or increased tendency for bleeding were reviewed to determine the occurrence of hypocoagulability. Events of clotting, thrombosis, pulmonary embolism, vaso-occlusive stroke, myocardial infarction, and any other term indicative of a clotting event or increased risk of clotting were reviewed to determine the occurrence of hypercoagulability.
12 months after first treatment
Secondary Outcomes (1)
Overall Patient Response Assessment
within 4 hours post dose
Study Arms (2)
Patients naive to KALBITOR
HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
Patients non- naive to KALBITOR
HAE patients that have been treated with KALBITOR prior to enrollment in the study
Interventions
30 mg SC
Eligibility Criteria
patients with hereditary angioedema, either naive or non-naive to KALBITOR (ecallantide) prior to enrollment in the study
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Shirelead
Study Sites (40)
Little Rock Allergry and Asthma Clinical Research Center
Little Rock, Arkansas, 72205, United States
Sunrise Clinical Research
Bell Gardens, California, 90201, United States
Allergy & Asthma Institute of the Valley
Granada Hills, California, 91344, United States
Unidversity of California, Los Angeles David Geffen School of Medicine
Los Angeles, California, 90095-1680, United States
705 West LaVeta
Orange, California, 92868, United States
Allergy & Asthma Clinical Research Inc.
Walnut Creek, California, 94598, United States
Center for Allergy, Asthma & Immunology
Waterbury, Connecticut, 06708, United States
University of South Florida Asthma
Tampa, Florida, 33613, United States
Brookstone Clinical Research Center
Columbus, Georgia, 31904, United States
University Consultants in Allergry and Immunology
Chicago, Illinois, 60612, United States
Deaconess Clinic Downtown
Evansville, Indiana, 47713, United States
Muncie Allergy Ctr
Muncie, Indiana, 47304, United States
Kansas City Allergy and Asthma Associates
Overland Park, Kansas, 66210, United States
Ochsner Health System - Allergy, Asthma and Immunology Department
Jefferson, Louisiana, 70121, United States
Clinical Research Specialists
Metairie, Louisiana, 70006, United States
Institute for Asthma and Allergy, P.C.
Chevy Chase, Maryland, 20815, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, 02467, United States
University of Michigan Health System Allergy Specialty Clinic
Ann Arbor, Michigan, 48105, United States
Asthma and Allergy Institute of Michigan
Clinton Township, Michigan, 48038, United States
Saint Louis University School of Medicine
St Louis, Missouri, 63104, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of Nevada School of Medicine - Department of Pediatrics
Reno, Nevada, 89503, United States
Allergy Treatment Center of New Jersey
Iselin, New Jersey, 08830, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Medical Research Associates of CNY
North Syracuse, New York, 13212, United States
Unknown Facility
The Bronx, New York, 10465, United States
Allergy Partners of Western North Carolina
Asheville, North Carolina, 28801, United States
Specialty Medical Clinic And Research Center
Sanford, North Carolina, 27330, United States
Department of Internal Medicine, University of Cincinnati -MSB
Cincinnati, Ohio, 45267-0563, United States
Optimed Research, LTD
Columbus, Ohio, 43235, United States
Reynolds Clinic
Toledo, Ohio, 43615, United States
Toledo Institute of Clinical Research
Toledo, Ohio, 43617, United States
Allergy Clinic of the Tulsa, Inc.
Tulsa, Oklahoma, 74133, United States
Penn State University - Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033-0850, United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224, United States
AARA Research Center
Dallas, Texas, 75231, United States
University of Utah, Department of Dermatology
Salt Lake City, Utah, 84132, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507, United States
Unknown Facility
Virginia Beach, Virginia, 23452, United States
Puget Sound Allergy, Asthma and Immunology
Tacoma, Washington, 98405, United States
Biospecimen
serum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
44 patients (out of 200 planned) received treatment in this study. Additionally, the collection of evaluable efficacy data for the secondary endpoint was limited by a lack of response data collected for HAE attacks treated at alternate sites.
Results Point of Contact
- Title
- Study Director
- Organization
- Shire
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2010
First Posted
February 1, 2010
Study Start
February 1, 2010
Primary Completion
September 1, 2013
Study Completion
June 1, 2014
Last Updated
June 8, 2021
Results First Posted
October 6, 2014
Record last verified: 2021-05