CompletedPhase 3

C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks

United States83 participantsStarted 2005-03-14

Plain-language summary

The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.

Who can participate

Age range

6 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: * Documented HAE * Normal C1q level Exclusion Criteria: * Low C1q level * B-cell malignancy * Presence of anti-C1INH autoantibody * History of allergic reaction to C1INH or other blood products * Narcotic addiction * Current participation in any other investigational drug study or within the past 30 days * Participation in a C1 esterase inhibitor trial, or received blood or a blood product in the past 90 days * Pregnancy or lactation * Any clinically significant medical condition, such as renal failure, that in the opinion of the investigator would interfere with the subject's ability to participate in 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

Time to Beginning of Substantial Relief of the Defining Symptom

Timeframe: Within 4 hours after initial treatment

Trial details

NCT IDNCT00289211

SponsorShire

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2007-04-13

Results submitted2010-03-17

View on ClinicalTrials.gov More Hereditary Angioedema trials

Who can participate

Age range

6 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.