Trials / Completed
CompletedNCT01059526
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 81 (actual)
- Sponsor
- Shire · Industry
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ecallantide | 30 mg SC |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2013-09-01
- Completion
- 2014-06-01
- First posted
- 2010-02-01
- Last updated
- 2021-06-08
- Results posted
- 2014-10-06
Locations
40 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01059526. Inclusion in this directory is not an endorsement.