A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration

• Status: Completed
• Trial end date: 2010-04-01
• Target enrollment: 0
• Participant gender: All

Summary

Hereditary angioedema ("HAE") is a disease characterized by recurrent tissue swelling affecting various body locations. Recent literature shows that patients with frequent attacks may benefit from long-term prophylaxis. This study aims to evaluate the safety and prophylactic effect of weekly administrations of 50 IU/kg recombinant C1 Inhibitor ("rhC1INH").

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Aged at least 18 years

• Signed informed consent

• Comfirmed diagnosis of HAE with baseline plasma level of functional C1INH activity of less than 50% of normal, and/or proven HAE ,mutation in C1INH gene.

Exclusion Criteria:

• A history of anaphylaxis or severe allergy (i.e. requiring medication) to food, proteins and/or drugs.

• A history of allergic reactions to C1INH products or rabbit protein.

• Any reported SAE related to study drug administration (withdrawal criterium)

• Elevated IgE against rabbit dander (>0.35 kU/L; ImmunoCap assay; Phadia)

• A diagnosis of acquired C1INH deficiency.

• Woman of child bearing potential, pregnancy or breast-feeding

• previous treatment within the last 3 months with plasma-derived C1INH

• Any clinically significant abnormality in the routine haematology, biochemistry and urinalysis

• Any condition or treatment that in the opinion of the investigator might interfere with the evaluation of the study objectives.

• Any changes since screening that would exclude subject based on above exclusion criteria.