Berinert (C1 esterase inhibitor (human) IV) / CSL Behring  >>  Phase 3
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11 Trials

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Trial + Data / EventsStatusPhNRegionInterventionsSponsorConditionsPrimary complStudy compl
Berinert (C1 esterase inhibitor (human) IV) / CSL Behring
NCT00292981 / 2005-002897-31: C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study)

Completed
3
57
US, Canada
C1 Esterase Inhibitor, Berinert P
CSL Behring
Hereditary Angioedema
02/10
05/10
PASSION, NCT00748202 / 2008-000654-12: Berinert P Study of Subcutaneous Versus Intravenous Administration

Completed
3
24
Europe
C1-Esterase Inhibitor, Berinert P
Johann Wolfgang Goethe University Hospital, Clinical trial center Rhine-Main, ZKI Kindergerinnungslabor, Institut für Medizinische Virologie JWG-University hospital, CSL Behring, PharmaPart, University of Milan
Hereditary Angioedema
12/10
12/10
2010-019670-32: Pharmacokinetics and Safety of Human Pasteurised C1-Inhibitor Concentrate (Berinert/CE1145) in Subjects with Congenital C1-INH Deficiency. Studio della farmacocinetica e della sicurezza del C1-Inibitore concentrato pasteurizzato umano (Berinert/CE1145) in soggetti con deficienza congenita di C1-INH.

Ongoing
3
3
Europe
Powder and solvent for solution for injection, BERINERT*IV FL 500U+FL 10ML
AZIENDA OSPEDALIERA L. SACCO (A.O. DI RILIEVO NAZIONALE), CSL Behring
Hereditary Angioedema (HAE) angioedema ereditario, Hereditary Angioedema (HAE) angioedema ereditario, Diseases [C] - Blood and lymphatic diseases [C15]
 
 
2005-003139-38: C1 Esterase Inhibitor in Hereditary Angioedema (HAE) (Extension Study)

 
3
57
Canada, US
C1 esterase inhibitor concentrate, CE1145, Powder and solvent for solution for infusion, Berinert®
ZLB Behring GmbH, ZLB Behring GmbH
Congenital C1-INH deficiency, Congenital C1 esterase inhibitor (C1-INH) deficiency, Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
COMPACT, NCT01912456 / 2013-000916-10: A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

Completed
3
90
Europe, Canada, US, RoW
Low-volume C1-esterase inhibitor, Higher-volume C1-esterase inhibitor, Low-volume placebo, Higher-volume placebo
CSL Behring
Hereditary Angioedema Types I and II
10/15
10/15
NCT02316353 / 2014-001054-42: A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema

Completed
3
126
Canada, US, Europe, RoW
C1-esterase inhibitor
CSL Behring
Hereditary Angioedema Types I and II
09/17
09/17
NCT01843530 / 2012-001670-28: Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema

Completed
3
31
Europe
Berinert, Clemastin, Cortisone acetate, NaCl
Technical University of Munich
Acute ACE-induced Angioedema
10/18
09/19
2019-003921-99: Subcutaneous administration of human plasma-derived C1-esterase inhibitor for prevention of hereditary angioedema attacks in Japanese subjects

 
3
10
Japan
C1-esterase inhibitor (C1-INH), CSL830, Powder and solvent for solution for injection/infusion, Haegarda, Berinert
CSL Behring K.K., CSL Behring K.K.
Hereditary angiodema (HAE) type I and II are genetic disorders that are associated with a deficiency in C1 esterase-inhibitor, Hereditary angiodema type I and II, Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
 
 
NCT03221842 / 2017-000348-17: Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as add-on to Standard of Care for the Treatment of Refractory Antibody Mediated Rejection (AMR) in Adult Renal Transplant Recipients

Terminated
3
63
Europe, US
C1-esterase inhibitor, C1-INH, Placebo
CSL Behring
Antibody-mediated Rejection
01/21
01/21
NCT00168103 / 2004-001186-17: Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks

Completed
2/3
126
US, Canada, Europe, RoW
C1 Esterase Inhibitor, Berinert, Berinert P, CE1145, Placebo, Physiological saline solution
CSL Behring
Hereditary Angioedema
10/07
12/07
NCT04898309: Efficacy and Safety of GNR-038 vs Berinert® in Patients With Hereditary Angioedema

Withdrawn
2/3
0
RoW
GNR-038, 50 МЕ/ kg, Recombinant C1 esterase inhibitor, 50 МЕ/ kg, GNR-038, 100 МЕ/ kg, Recombinant C1 esterase inhibitor, 100 МЕ/ kg, Berinert®, 20 МЕ/ kg, Human C1 esterase inhibitor, Placebo, GNR-038. The dose will be selected according to results of stage 1 clinical trial., Recombinant C1 esterase inhibitor.
AO GENERIUM
Hereditary Angioedema
05/23
05/23

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