CompletedNot Applicable

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

United States81 participantsStarted 2010-02-01

Plain-language 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).

Who can participate

Age range16 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Occurrence of Anaphylaxis or Other Adverse Events Suggestive of Hypersensitivity

Timeframe: 12 months after first treatment

Occurrence of Seroconversion to Anti-ecallantide Antibodies Upon Exposure to KALBITOR.

Timeframe: 12 months after first treatment

Occurrence of Adverse Events Related to Disordered Coagulation (Hypercoagulability and Hypocoagulability) Upon Exposure to KALBITOR

Timeframe: 12 months after first treatment

Trial details

NCT IDNCT01059526

SponsorShire

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2013-09-01

Results submitted2014-09-10

View on ClinicalTrials.gov More Hereditary Angioedema (HAE) trials