Clinical trial NCT01059526: Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hereditary Angioedema (HAE)
Keywords: HAE
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2010-02-01
Enrollment: 81
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with hereditary angioedema, either naive or non-naive to KALBITOR (ecallantide) prior to enrollment in the study

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.

Eligibility 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

Primary outcomes:
measure: Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity
timeFrame: 12 months after first treatment
measure: Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.
timeFrame: 12 months after first treatment
measure: Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR
timeFrame: 12 months after first treatment
Secondary outcomes:
measure: Overall Patient Response Assessment
timeFrame: within 4 hours post dose
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Little Rock Allergry and Asthma Clinical Research Center
state: Arkansas
city: Bell Gardens
country: United States
facility: Sunrise Clinical Research
state: California
city: Granada Hills
country: United States
facility: Allergy & Asthma Institute of the Valley
state: California
city: Los Angeles
country: United States
facility: Unidversity of California, Los Angeles David Geffen School of Medicine
state: California
city: Orange
country: United States
facility: 705 West LaVeta
state: California
city: Walnut Creek
country: United States
facility: Allergy & Asthma Clinical Research Inc.
state: California
city: Waterbury
country: United States
facility: Center for Allergy, Asthma & Immunology
state: Connecticut
city: Tampa
country: United States
facility: University of South Florida Asthma
state: Florida
city: Columbus
country: United States
facility: Brookstone Clinical Research Center
state: Georgia
city: Chicago
country: United States
facility: University Consultants in Allergry and Immunology
state: Illinois
city: Evansville
country: United States
facility: Deaconess Clinic Downtown
state: Indiana
city: Muncie
country: United States
facility: Muncie Allergy Ctr
state: Indiana
city: Overland Park
country: United States
facility: Kansas City Allergy and Asthma Associates
state: Kansas
city: Jefferson
country: United States
facility: Ochsner Health System - Allergy, Asthma and Immunology Department
state: Louisiana
city: Metairie
country: United States
facility: Clinical Research Specialists
state: Louisiana
city: Chevy Chase
country: United States
facility: Institute for Asthma and Allergy, P.C.
state: Maryland
city: Chestnut Hill
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System Allergy Specialty Clinic
state: Michigan
city: Clinton Township
country: United States
facility: Asthma and Allergy Institute of Michigan
state: Michigan
city: Saint Louis
country: United States
facility: Saint Louis University School of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Reno
country: United States
facility: University of Nevada School of Medicine - Department of Pediatrics
state: Nevada
city: Iselin
country: United States
facility: Allergy Treatment Center of New Jersey
state: New Jersey
city: Bronx
country: United States
state: New York
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: North Syracuse
country: United States
facility: Medical Research Associates of CNY
state: New York
city: Asheville
country: United States
facility: Allergy Partners of Western North Carolina
state: North Carolina
city: Sanford
country: United States
facility: Specialty Medical Clinic And Research Center
state: North Carolina
city: Cincinnati
country: United States
facility: Department of Internal Medicine, University of Cincinnati -MSB
state: Ohio
city: Columbus
country: United States
facility: Optimed Research, LTD
state: Ohio
city: Toledo
country: United States
facility: Reynolds Clinic
state: Ohio
city: Toledo
country: United States
facility: Toledo Institute of Clinical Research
state: Ohio
city: Tulsa
country: United States
facility: Allergy Clinic of the Tulsa, Inc.
state: Oklahoma
city: Hershey
country: United States
facility: Penn State University - Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC
state: Pennsylvania
city: Dallas
country: United States
facility: AARA Research Center
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Department of Dermatology
state: Utah
city: Norfolk
country: United States
facility: Children's Hospital of the King's Daughters
state: Virginia
city: Virginia Beach
country: United States
state: Virginia
city: Tacoma
country: United States
facility: Puget Sound Allergy, Asthma and Immunology
state: Washington
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: