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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dyax Corp.
ClinicalTrials.gov Identifier:
NCT01059526
First received: January 28, 2010
Last updated: October 2, 2014
Last verified: October 2014

January 28, 2010
October 2, 2014
February 2010
September 2013   (final data collection date for primary outcome measure)
  • Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity [ Time Frame: 12 months after first treatment ] [ Designated as safety issue: Yes ]
    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.
  • Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR. [ Time Frame: 12 months after first treatment ] [ Designated as safety issue: Yes ]

    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 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 ]
    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.
  • 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 ]
  • Occurence of anaphylaxis or other adverse events suggestive of hypersensitivity [ Time Frame: 12 months after first treatment ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT01059526 on ClinicalTrials.gov Archive Site
Overall Patient Response Assessment [ Time Frame: within 4 hours post dose ] [ Designated as safety issue: No ]
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.
Overall Patient Response Assessment [ Time Frame: 90 minutes post-dose ] [ Designated as safety issue: No ]
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) prior to enrollment in the study

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.
 
Completed
81
June 2014
September 2013   (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.
October 2014

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