N/A
Completed N=81
Observational Safety Study for KALBITOR (Ecallantide) in the Treatment of Acute Attacks of Hereditary Angioedema
Hereditary Angioedema (HAE)
Source: ClinicalTrials.gov NCT01059526 ↗
Enrolled (actual)
81
Serious AEs
13.6%
Results posted
Oct 2014
Primary outcomePrimary: Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity — 4; 2 participants
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity |
4; 2 | — |
| PRIMARY Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR. |
6; 0; 5 | — |
| PRIMARY Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR |
— | — |
| SECONDARY Overall Patient Response Assessment |
10; 15; 1; 2; 0; 0 | — |
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
Data sourced from ClinicalTrials.gov (NCT01059526). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.