Phase 3
Completed N=24
C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks
Source: ClinicalTrials.gov NCT01005888 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Jun 2010
Primary outcomePrimary: Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period — 6.1; 12.7; 6.3; 12.7 attacks — p=<0.0001
Summary
The study objective was to determine the safety and efficacy of C1INH-nf for the prevention of acute HAE attacks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period |
6.1; 12.7; 6.3; 12.7 | <0.0001 sig |
| SECONDARY Number of Subject Withdrawals During Each Prophylactic Therapy Period |
1; 1; 1; 1 | >0.999 |
| SECONDARY Average Severity of HAE Attacks During Each Prophylactic Therapy Period |
1.3; 1.9 | 0.0008 sig |
| SECONDARY Average Duration of HAE Attacks During Each Prophylactic Therapy Period |
2.1; 3.4 | 0.0004 sig |
| SECONDARY Number of Open-label C1INH-nf Infusions Required During Each Prophylactic Therapy Period |
4.7; 15.4 | <0.0001 sig |
| SECONDARY Antigenic C1 Inhibitor (C1INH) Serum Levels |
14.3; 14.2; 7.9; -0.1; 9.8; 0.1 | <0.0001 sig |
| SECONDARY Functional C1INH Serum Levels |
33.9; 31.7; 32.0; -2.4; 36.6; 5.3 | <0.0001 sig |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01005888). 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.