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 range

16 Years

Sex

ALL

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

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

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