Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks
Completed · Phase 3 · Has a placebo group
Conditions studied: Hereditary Angioedema
In brief
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.
Key facts
- Study ID
- NCT01188564
- Run by
- Pharming Technologies B.V.
- People needed
- 75
- Starts
- 2011-01-01
- Expected to finish
- 2013-03-01
- Last updated by the study team
- 2015-08-07
Who can join
Age: 13 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Allergy, Asthma & Immunology, Assoc, Ltd. — Scottsdale, Arizona, United States
- Allergy and Asthma Institute of the Valley — Granada Hills, California, United States
- UCLA Department of Medicine Division of Clinical Immunology, David Geffen School of Medicine — Los Angeles, California, United States
- USF Asthma, Allergy and Immunology Clinical Research Unit — Tampa, Florida, United States
- Family Allergy and Asthma Center — Atlanta, Georgia, United States
- Institute for Asthma and Allergy, P.C. — Chevy Chase, Maryland, United States
- Asthma & Allergy Center - Washington University School of Medicine — St Louis, Missouri, United States
- University of Cincinnati Physicians, Inc. — Cincinnati, Ohio, United States
- Optimed Research, LTD — Columbus, Ohio, United States
- Baker Allergy, Asthma and Dermatology Research Center, LLC — Lake Oswego, Oregon, United States
- Pennsylvania State- Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States
- AARA Research Center — Dallas, Texas, United States
- University of Texas - Medical Branch — Galveston, Texas, United States
- Allergy, Asthma & Immunology Clinic, P.A. — Irving, Texas, United States
- Marycliff Allergy Specialists — Spokane, Washington, United States
- UMHAT "Tsaritsa Yoanna - ISUL"; Clinic of Ear-Nose-Throat Diseases — Sofia, Bulgaria
- Ottawa Allergy Research Corp. — Ottawa, Ontario, Canada
- Semmelweis University Faculty of Medicine, III Department of Internal Medicine — Budapest, Hungary
- Allergy, Immunology & Angioedema Center, — Tel Litwinsky, Ramat Gan, Israel
- Bnei-Zion Medical Centre, Clinical Immunology and Allergy Division — Haifa, Israel
- Ospedale Luigi Sacco, Azienda Ospedaliera - Polo Universitario II Divisione di Medicina Interna — Milan, Italy
- P.H.U. Clinic for Dermatology, Medical University Skopje, Unit of Allergology and Clinical Immunology — Skopje, North Macedonia
- Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Klinik Chorób Wewnętrznych, Poradnia Alergologiczna — Krakow, Poland
- Spitalul Clinic Judeţean Mureş Secţia Clinică Medicină Internă, Compartimentul de Alergologie şi Imunologie — Târgu Mureş, Romania
- Clinic for Immunology and Allergology — Belgrade, Serbia
Full record on ClinicalTrials.gov
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