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

Hereditary Angioedema (HAE) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01059526
• Other study ID #: DX-88/24
• Status: Completed
• Start date: February 1, 2010
• Est. completion date: June 1, 2014

Study information

• Verified date: May 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: June 1, 2014
• Est. primary completion date: September 1, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema (HAE)

Intervention

Drug:
• ecallantide
30 mg SC

Locations

Country	Name	City	State
United States	University of Michigan Health System Allergy Specialty Clinic	Ann Arbor	Michigan
United States	Allergy Partners of Western North Carolina	Asheville	North Carolina
United States	Sunrise Clinical Research	Bell Gardens	California
United States	Brigham and Women's Hospital	Chestnut Hill	Massachusetts
United States	Institute for Asthma and Allergy, P.C.	Chevy Chase	Maryland
United States	University Consultants in Allergry and Immunology	Chicago	Illinois
United States	Department of Internal Medicine, University of Cincinnati -MSB	Cincinnati	Ohio
United States	Asthma and Allergy Institute of Michigan	Clinton Township	Michigan
United States	Brookstone Clinical Research Center	Columbus	Georgia
United States	Optimed Research, LTD	Columbus	Ohio
United States	AARA Research Center	Dallas	Texas
United States	Deaconess Clinic Downtown	Evansville	Indiana
United States	Allergy & Asthma Institute of the Valley	Granada Hills	California
United States	Penn State University - Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania
United States	Allergy Treatment Center of New Jersey	Iselin	New Jersey
United States	Ochsner Health System - Allergy, Asthma and Immunology Department	Jefferson	Louisiana
United States	Little Rock Allergry and Asthma Clinical Research Center	Little Rock	Arkansas
United States	Unidversity of California, Los Angeles David Geffen School of Medicine	Los Angeles	California
United States	Clinical Research Specialists	Metairie	Louisiana
United States	Winthrop University Hospital	Mineola	New York
United States	Muncie Allergy Ctr	Muncie	Indiana
United States	Children's Hospital of the King's Daughters	Norfolk	Virginia
United States	Medical Research Associates of CNY	North Syracuse	New York
United States	705 West LaVeta	Orange	California
United States	Kansas City Allergy and Asthma Associates	Overland Park	Kansas
United States	Children's Hospital of Pittsburgh of UPMC	Pittsburgh	Pennsylvania
United States	University of Nevada School of Medicine - Department of Pediatrics	Reno	Nevada
United States	Saint Louis University School of Medicine	Saint Louis	Missouri
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah, Department of Dermatology	Salt Lake City	Utah
United States	Specialty Medical Clinic And Research Center	Sanford	North Carolina
United States	Puget Sound Allergy, Asthma and Immunology	Tacoma	Washington
United States	University of South Florida Asthma	Tampa	Florida
United States	Reynolds Clinic	Toledo	Ohio
United States	Toledo Institute of Clinical Research	Toledo	Ohio
United States	Allergy Clinic of the Tulsa, Inc.	Tulsa	Oklahoma
United States	Allergy & Asthma Clinical Research Inc.	Walnut Creek	California
United States	Center for Allergy, Asthma & Immunology	Waterbury	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Overall Patient Response Assessment	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.	within 4 hours post dose