Phase 3
N=75
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
Hereditary Angioedema
Bottom Line
View on ClinicalTrials.gov: NCT01188564 ↗Enrolled (actual)
75
Serious AEs
1.4%
Results posted
Aug 2015
Primary outcome: Primary: Time to Beginning of Relief of Symptoms — 90; 152 minutes
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- rhC1INH (Drug); Placebo (Saline) (Drug)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- Pharming Technologies B.V.
- Primary completion
- Dec 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Beginning of Relief of Symptoms |
90; 152 | — |
| SECONDARY Time to Minimal Symptoms |
303; 483 | — |
Summary
This study is being conducted to confirm the efficacy, safety, and immunogenicity of recombinant human C1 inhibitor (rhC1INH) at a dose of 50 U/kg when used for the treatment of acute angioedema attacks in Hereditary Angioedema (HAE) patients.
Eligibility Criteria
Inclusion Criteria
- Aged at least 13 years
- Signed written informed consent
- Clear clinical and laboratory diagnosis of HAE with baseline plasma level of functional C1INH of less than 50% of normal
- Willingness and ability to comply with all protocol procedures
- Clinical symptoms of an eligible HAE attack with onset less than 5 hours before the time of initial evaluation
Exclusion Criteria
- Medical history of allergy to rabbits or rabbit-derived products (including rhC1INH), or positive anti-rabbit dander IgE test (cut off >0.35 kU/L; ImmunoCap® assay; Phadia or equivalent).
- A diagnosis of acquired C1INH deficiency (AAE)
- Pregnancy, or breastfeeding, or current intention to become pregnant
- Treatment with any investigational drug in the past 30 days
- Known or suspected addiction to drug and/or alcohol abuse
- Suspicion for an alternate explanation of the symptoms other than acute HAE attack
Data sourced from ClinicalTrials.gov (NCT01188564). 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.