Status:
COMPLETED
A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration
Lead Sponsor:
Pharming Technologies B.V.
Conditions:
Genetic Disorders
Hereditary Angioedema
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 lon...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2010
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00851409
Start Date
June 1 2009
End Date
April 1 2010
Last Update
June 26 2018
Active Locations (2)
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1
For information on sites, please contact Pharming Technologies
Leiden, Netherlands
2
Emergency County Hospital, Internal Medicin Clinica, Allergology-Immunology Department
Târgu Mureş, Romania, 541103