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

PHASE3CompletedINTERVENTIONAL
Enrollment

75

Participants

Timeline

Start Date

January 31, 2011

Primary Completion Date

December 31, 2012

Study Completion Date

March 31, 2013

Conditions
Hereditary Angioedema
Interventions
DRUG

rhC1INH

One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.

DRUG

Placebo (Saline)

One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment

Trial Locations (27)

1000

P.H.U. Clinic for Dermatology, Medical University Skopje, Unit of Allergology and Clinical Immunology, Skopje

1527

"UMHAT Tsaritsa Yoanna - ISUL; Clinic of Ear-Nose-Throat Diseases", Sofia

2193

Wits Health Consortium (Pty) Ltd - Wits Donald Gordon Medical Centre, Parktown

7700

Allergy Diagnostic & Clinical Research Unit University of Cape Town Lung Institute, Mowbray

11000

Clinic for Immunology and Allergology, Belgrade

17033

Pennsylvania State- Milton S. Hershey Medical Center, Hershey

20157

Ospedale Luigi Sacco, Azienda Ospedaliera - Polo Universitario II Divisione di Medicina Interna, Milan

20815

Institute for Asthma and Allergy, P.C., Chevy Chase

30342

Family Allergy and Asthma Center, Atlanta

31048

Bnei-Zion Medical Centre, Clinical Immunology and Allergy Division, Haifa

33613

USF Asthma, Allergy and Immunology Clinical Research Unit, Tampa

43235

Optimed Research, LTD, Columbus

45267

University of Cincinnati Physicians, Inc., Cincinnati

52621

Allergy, Immunology & Angioedema Center,, Tel Litwinsky

63141

Asthma & Allergy Center - Washington University School of Medicine, St Louis

75063

Allergy, Asthma & Immunology Clinic, P.A., Irving

75231

AARA Research Center, Dallas

77555

University of Texas - Medical Branch, Galveston

85251

Allergy, Asthma & Immunology, Assoc, Ltd., Scottsdale

90095

UCLA Department of Medicine Division of Clinical Immunology, David Geffen School of Medicine, Los Angeles

91344

Allergy and Asthma Institute of the Valley, Granada Hills

97035

Baker Allergy, Asthma and Dermatology Research Center, LLC, Lake Oswego

99204

Marycliff Allergy Specialists, Spokane

540103

Spitalul Clinic Judeţean Mureş Secţia Clinică Medicină Internă, Compartimentul de Alergologie şi Imunologie, Târgu Mureş

KIY 4G2

Ottawa Allergy Research Corp., Ottawa

H-1125

Semmelweis University Faculty of Medicine, III Department of Internal Medicine, Budapest

31-531

Szpital Uniwersytecki w Krakowie, Oddział Kliniczny Klinik Chorób Wewnętrznych, Poradnia Alergologiczna, Krakow

Sponsors
All Listed Sponsors
lead

Pharming Technologies B.V.

INDUSTRY

NCT01188564 - Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks | Biotech Hunter | Biotech Hunter