Phase 3
Completed N=83
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks
Source: ClinicalTrials.gov NCT00289211 ↗Enrolled (actual)
83
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcomePrimary: Time to Beginning of Substantial Relief of the Defining Symptom — 2.0; 4.0 hours — p=0.048
Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the treatment of acute HAE attacks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Beginning of Substantial Relief of the Defining Symptom |
2.0; 4.0 | 0.048 sig |
| SECONDARY Number of Subjects With Beginning of Substantial Relief of the Defining Symptom |
21; 14 | 0.062 |
| SECONDARY Time to Complete Resolution of the HAE Attack |
12.3; 31.6 | 0.001 sig |
| SECONDARY Antigenic C1 Inhibitor (C1INH) Serum Levels |
14.7; 13.0; 6.7; -0.9; 11.7; 0.5 | <0.0001 sig |
| SECONDARY Functional C1INH Serum Levels |
35.6; 33.7; 31.5; -6.4; 45.6; 1.0 | <0.0001 sig |
| SECONDARY Complement C4 Serum Levels |
8.1; 6.7; -0.7; -0.9; -1.7; -1.1 | 0.1321 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00289211). 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.