C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks (NCT01005888) | Clinical Trial Compass
CompletedPhase 3
C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
United States26 participantsStarted 2005-03-14
Plain-language summary
The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.
Who can participate
Age range6 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:
* Documented HAE
* Normal C1q level
* Relatively frequent angioedema attacks (at least 2 per month on average)
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
What they're measuring
1
Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period