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

This study is ongoing, but not recruiting participants.
Sponsor:
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
History of Changes

January 28, 2010
April 3, 2013
February 2010
February 2014   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01059526 on ClinicalTrials.gov Archive Site
Overall Patient Response Assessment [ Time Frame: 90 minutes post-dose ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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).

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum
Non-Probability Sample

patients with hereditary angioedema, either naive or non-naive to KALBITOR (ecallantide)
Hereditary Angioedema
Drug: ecallantide
30 mg SC
Other Name: Kalbitor
  • Patients naive to KALBITOR
    HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
    Intervention: Drug: ecallantide
  • Patients non- naive to KALBITOR
    HAE patients that have been treated with KALBITOR prior to enrollment in the study
    Intervention: Drug: ecallantide
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
200
February 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01059526
DX-88/24
Yes
Dyax Corp.
Dyax Corp.
Not Provided
Study Director: Yung Chyung, MD Dyax Corp.
Dyax Corp.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP