Phase 3
Completed N=146
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Source: ClinicalTrials.gov NCT00462709 ↗Enrolled (actual)
146
Serious AEs
0.0%
Results posted
May 2010
Primary outcomePrimary: Frequency of All HAE Attacks — 3.00; 0.21 attacks per month
Summary
The study objective was to evaluate the safety and efficacy of prophylactic use of C1INH-nf for the prevention of acute HAE attacks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of All HAE Attacks |
3.00; 0.21 | — |
Eligibility Criteria
Inclusion Criteria
- History of at least 1 HAE attack per month or any history of laryngeal edema
In addition, this study was open to all subjects who:
- Completed participation in LEVP2005-1/B (NCT01005888) any time after the final prophylactic therapy in Part B
- Were enrolled but not randomized in LEVP2005-1/A (NCT00289211) after Part A was closed
- Were enrolled and randomized in LEVP2005-1/A after LEVP2005-1/B was closed to enrollment, any time after the 3-day telephone follow-up
- Were excluded from LEVP2005-1 for any of the following reasons:
- Pregnancy or lactation
- Age less than 6 years
- Narcotic addiction
- Presence of anti-C1 inhibitor (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 other than those sponsored by Lev Pharmaceuticals
- Received blood or a blood product in the past 60 days other than C1INH-nf
Data sourced from ClinicalTrials.gov (NCT00462709). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.