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
  Purpose

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).


Condition Intervention
Hereditary Angioedema
Drug: ecallantide

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Dyax Corp.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Overall Patient Response Assessment [ Time Frame: 90 minutes post-dose ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum


Estimated Enrollment: 200
Study Start Date: February 2010
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Patients naive to KALBITOR
HAE patients that have not been treated with KALBITOR (ecallantide) prior to enrollment in the study
Drug: ecallantide
30 mg SC
Other Name: Kalbitor
Patients non- naive to KALBITOR
HAE patients that have been treated with KALBITOR prior to enrollment in the study
Drug: ecallantide
30 mg SC
Other Name: Kalbitor

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with hereditary angioedema, either naive or non-naive to KALBITOR (ecallantide)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01059526

  Show 40 Study Locations
Sponsors and Collaborators
Dyax Corp.
Investigators
Study Director: Yung Chyung, MD Dyax Corp.
  More Information

No publications provided

Responsible Party: Dyax Corp.
ClinicalTrials.gov Identifier: NCT01059526     History of Changes
Other Study ID Numbers: DX-88/24
Study First Received: January 28, 2010
Last Updated: April 3, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Dyax Corp.:
HAE

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on September 18, 2014