Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks

• Status: Completed
• Trial end date: 2013-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharming Technologies B.V.
• Treatments: Complement C1 Inactivator Proteins

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