Status:
COMPLETED
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
Lead Sponsor:
Pharming Technologies B.V.
Conditions:
Hereditary Angioedema
Eligibility:
All Genders
13+ years
Phase:
PHASE3
Brief 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 attac...
Detailed Description
HAE is characterized by recurrent localized angioedema caused by uncontrolled activation of the complement and contact systems due to a congenital deficiency of functional C1 inhibitor. rhC1INH has b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT01188564
Start Date
January 1 2011
End Date
March 1 2013
Last Update
August 7 2015
Active Locations (27)
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1
Allergy, Asthma & Immunology, Assoc, Ltd.
Scottsdale, Arizona, United States, 85251
2
Allergy and Asthma Institute of the Valley
Granada Hills, California, United States, 91344
3
UCLA Department of Medicine Division of Clinical Immunology, David Geffen School of Medicine
Los Angeles, California, United States, 90095
4
USF Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States, 33613