MedPath

Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema

Completed
Conditions
Hereditary Angioedema (HAE)
Interventions
Registration Number
NCT01059526
Lead Sponsor
Shire
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).

Detailed Description

The objective of this study is to evaluate immunogenicity and hypersensitivity upon exposure to KALBITOR, in particular:

1. Determine the rate of anaphylaxis and Type I hypersensitivity reactions upon exposure to KALBITOR.

2. Determine the rate of seroconversion to anti-ecallantide antibodies upon exposure to KALBITOR.

3. Determine the rate of adverse events related to disordered coagulation (hypercoagulability and hypocoagulability) upon exposure to KALBITOR.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
81
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Arm && Interventions
GroupInterventionDescription
Patients naive to KALBITORecallantideHAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
Patients non- naive to KALBITORecallantideHAE patients that have been treated with KALBITOR prior to enrollment in the study
Primary Outcome Measures
NameTimeMethod
Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR12 months after first treatment

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.

Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.12 months after first treatment

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.

Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity12 months after first treatment

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.

Secondary Outcome Measures
NameTimeMethod
Overall Patient Response Assessmentwithin 4 hours post dose

The Overall Response Assessment was to be completed every 30 minutes after treatment until patient discharge. Patients evaluated their response to treatment as "a lot better or resolved," "a little better," "the same," "a little worse," or "a lot worse." The data presented is based on the best response achieved following a single dose of KALBITOR (Dose A) for the first HAE treatment episode. Responses of "a lot better or resolved" and "a little better" were combined to form a category of "Better." Similarly, "a little worse" and "a lot worse" were combined to form a category of "Worse." Patients treated in a clinic (study site) could have been discharged after an hour and hence may have only had 2 post-treatment evaluations (30 and 60 minutes); response assessments may not have been consistently provided when patients were treated at an alternate site outside of the study site.

Trial Locations

Locations (38)

Little Rock Allergry and Asthma Clinical Research Center

🇺🇸

Little Rock, Arkansas, United States

Sunrise Clinical Research

🇺🇸

Bell Gardens, California, United States

Allergy & Asthma Institute of the Valley

🇺🇸

Granada Hills, California, United States

Unidversity of California, Los Angeles David Geffen School of Medicine

🇺🇸

Los Angeles, California, United States

705 West LaVeta

🇺🇸

Orange, California, United States

Allergy & Asthma Clinical Research Inc.

🇺🇸

Walnut Creek, California, United States

Center for Allergy, Asthma & Immunology

🇺🇸

Waterbury, Connecticut, United States

University of South Florida Asthma

🇺🇸

Tampa, Florida, United States

Brookstone Clinical Research Center

🇺🇸

Columbus, Georgia, United States

University Consultants in Allergry and Immunology

🇺🇸

Chicago, Illinois, United States

Scroll for more (28 remaining)
Little Rock Allergry and Asthma Clinical Research Center
🇺🇸Little Rock, Arkansas, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.