Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE… (NCT00438815) | Clinical Trial Compass
CompletedPhase 3
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
United States113 participantsStarted 2006-09-21
Plain-language summary
The study objective was to evaluate the safety and efficacy of repeat use of C1INH-nf for the treatment of acute HAE attacks.
Who can participate
Age range1 Year
SexALL
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Inclusion Criteria:
This study was open to all subjects who:
* Completed participation in LEVP2005-1/A (NCT00289211) and were not participating in LEVP2005-1/B (NCT01005888), any time after the 3-day telephone follow-up
* Completed participation in LEVP2005-1/B any time after the final prophylactic therapy in Part B
* Were enrolled but not randomized in LEVP2005-1/A after Part A was closed
* Were excluded from LEVP2005-1 for any of the following reasons:
* Pregnancy or lactation
* Age less than 6 years
* Narcotic addiction
* Presence of anti-C1INH autoantibodies
* Were not enrolled in LEVP2005-1 after enrollment in LEVP2005-1 was closed, under the following circumstances:
* Had a diagnosis of HAE: evidence of a low C4 level plus either a low C1INH antigenic level or a low C1INH functional level, or
* Had a known HAE-causing C1INH mutation, or
* Had a diagnosis of HAE based on a strong family history of HAE as determined by the principal investigator
Exclusion Criteria:
* History of allergic reaction to C1INH or other blood products
* Participated in any other investigational drug study within the past 30 days
* Received blood or a blood product in the past 60 days other than C1INH-nf
What they're measuring
1
Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf
Timeframe: Duration of the study (2.5 years)
2
Percent of HAE Attacks With Substantial Relief of the Defining Symptom