| 1 |
NCT03051698 |
Recruiting |
C1-inhibitor in Allergic ASThma Patients |
|
- Drug: C1-inhibitor
- Other: Saline
- Drug: Antibiotics
|
Interventional |
Phase 4 |
- T. van der Poll
- ZonMw: The Netherlands Organisation for Health Research and Development
- Sanquin
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Influx of inflammatory cells in the lung
- Interleukin-4 in pg/ml.
- Interleukin-5 in pg/ml.
- (and 18 more...)
|
60 |
All |
18 Years to 45 Years (Adult) |
NCT03051698 |
2015_024 |
CAST |
November 16, 2016 |
November 16, 2018 |
November 16, 2018 |
February 14, 2017 |
February 7, 2018 |
|
- Academic Medical Center
Amsterdam, Noord-Holland, Netherlands
|
| 2 |
NCT01134510 |
Completed
Has Results |
Safety & Tolerability of Berinert® (C1 Inhibitor) Therapy to Prevent Rejection |
|
- Drug: C1 Esterase Inhibitor
- Drug: Placebos
|
Interventional |
Phase 1
Phase 2 |
- Stanley Jordan, MD
- CSL Behring
- Cedars-Sinai Medical Center
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Post-transplant Biopsy to Identify Rejection Episodes
- Serum Creatinine
- Donor Specific Antibodies [DSA] Class I
- Donor Specific Antibodies [DSA] Class II
|
20 |
All |
18 Years to 65 Years (Adult) |
NCT01134510 |
C1INH001CSMC |
|
August 2011 |
November 2013 |
November 2013 |
June 2, 2010 |
March 21, 2017 |
August 3, 2015 |
- Cedars-Sinai medical center
Los Angeles, California, United States
|
| 3 |
NCT00748202 |
Completed |
Berinert P Study of Subcutaneous Versus Intravenous Administration |
|
- Drug: C1-Esterase Inhibitor
|
Interventional |
Phase 3 |
- Johann Wolfgang Goethe University Hospital
- Clinical trial center Rhine-Main
- ZKI Kindergerinnungslabor
- (and 4 more...)
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- Individual courses of C1-inhibitor levels, from these will be derived pharmacokinetic parameters
- Safety of s.c. and i.v. administration of study medication
|
24 |
All |
18 Years and older (Adult, Senior) |
NCT00748202 |
CE1145_1001 |
PASSION |
September 2008 |
December 2010 |
December 2010 |
September 8, 2008 |
January 19, 2011 |
|
- Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Centre for Thrombosis and Haemostasis, Johann-Wolfgang-Goethe-University Hospital
Frankfurt, Hessen, Germany
|
| 4 |
NCT01108848 |
Completed |
Patient Registry Study of Berinert® in Normal Clinical Practice |
- Includes: Hereditary Angioedema
|
- Biological: Berinert® (C1 Esterase Inhibitor)
|
Observational |
|
- CSL Behring
- Chiltern International Inc.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Incidence of thrombotic and thrombo-embolic events
- Occurrence of suspected viral transmission
- Use of concomitant medications and plasma products
|
318 |
All |
Child, Adult, Senior |
NCT01108848 |
CE1145_5002
1500 |
|
April 2010 |
April 2014 |
April 2014 |
April 22, 2010 |
June 9, 2014 |
|
- United States, Arizona
Scottsdale, Arizona, United States - United States, California
Granada Hills, California, United States - United States, California
Los Angeles, California, United States - (and 37 more...)
|
| 5 |
NCT01467947 |
Completed
Has Results |
Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert |
- Hereditary Angioedema Types I and II
|
- Biological: Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Subjects With Inhibitory Anti-C1-esterase-inhibitor Antibodies
- Number of Subjects With Any (Inhibitory or Non-inhibitory) Anti-C1-esterase-inhibitor Antibodies
|
46 |
All |
12 Years and older (Child, Adult, Senior) |
NCT01467947 |
CE1145_4001
2010-024242-30 |
|
November 2011 |
October 2014 |
October 2014 |
November 9, 2011 |
February 6, 2017 |
November 16, 2015 |
- MHAT "Tsaritsa Yoanna"
Sofia, Bulgaria - Semmelweis University
Budapest, Hungary - Jagiellonian University
Krakow, Poland - Spitalul Clinic Judeţean Mureş,Secţia Clinică Medicină Internă,Compartimentul Alergologie şi Imunologie
Târgu-Mures, Mureş, Romania
|
| 6 |
NCT01760343 |
Completed |
A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor |
- Hereditary Angioedema Types I and II
|
- Biological: Berinert
- Biological: CSL830
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Incidence of adverse events (AEs) within 24 hours of CSL830 infusion
- Incidence of adverse events (AEs) within 10 days of the CSL830 infusion
- Relative bioavailability of CSL830 versus Berinert - Cmax
- Relative bioavailability of CSL830 versus Berinert - AUC
|
16 |
All |
18 Years to 45 Years (Adult) |
NCT01760343 |
CSL830_1001
2012-002429-31 |
|
January 2013 |
March 2013 |
March 2013 |
January 4, 2013 |
April 5, 2013 |
|
- Study Site
Berlin, Germany
|
| 7 |
NCT02134314 |
Completed |
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI |
- End Stage Renal Disease
- Kidney Failure
- Delayed Graft Function
- Ischemic Reperfusion Injury
|
- Drug: C1 Esterase Inhibitor
- Drug: Placebo
|
Interventional |
Phase 1
Phase 2 |
- Cedars-Sinai Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Number of patients enrolled with serum creatinine >3mg/dL on postoperative day 5.
- Number of patients enrolled who require at least one session of dialysis in the first 7 days post transplant.
- Number of patients with serum creatinine reduction ratio of < 30% from 24 to 48 hours post-transplant.
- (and 6 more...)
|
70 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02134314 |
C1INH (Berinert) for DGF
IND15806 |
C1INHDGF |
September 2014 |
March 13, 2017 |
March 13, 2017 |
May 9, 2014 |
December 20, 2017 |
|
- Cedars-Sinai Medical Center
Los Angeles, California, United States
|
| 8 |
NCT00292981 |
Completed
Has Results |
C1 Esterase Inhibitor in Hereditary Angioedema (HAE)(Extension Study) |
|
- Drug: C1 Esterase Inhibitor
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to Start of Relief of Symptoms From HAE Attack (Intent to Treat (ITT) Subject Population)
- Time to Start of Relief of Symptoms From HAE Attack (ITT Attack Population)
- Time to Complete Resolution of All HAE Symptoms (ITT Subject Population)
- Time to Complete Resolution of All HAE Symptoms (ITT Attack Population)
|
57 |
All |
6 Years and older (Child, Adult, Senior) |
NCT00292981 |
CE1145_3003
1453 |
|
August 2005 |
February 2010 |
May 2010 |
February 16, 2006 |
May 7, 2015 |
June 23, 2011 |
- Contact CSL Behring for facility details
Weston, Florida, United States - Contact CSL Behring for facility details
Atlanta, Georgia, United States - Contact CSL Behring for facility details
Idaho Falls, Idaho, United States - (and 11 more...)
|
| 9 |
NCT02247739 |
Completed
Has Results |
A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor |
|
- Biological: Recombinant human C1 inhibitor
- Other: Placebo
|
Interventional |
Phase 2 |
- Pharming Technologies B.V.
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Number of HAE Attacks
- Number of Participants With Adverse Events
- Percentage of Participants Achieving at Least 50% Reduction in Number of Attacks
|
32 |
All |
13 Years and older (Child, Adult, Senior) |
NCT02247739 |
C1 3201 |
|
December 2014 |
May 2016 |
September 2016 |
September 25, 2014 |
December 8, 2017 |
December 8, 2017 |
- University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States - University of South Florida, Asthma, Allergy & Immunology Clinical Research Unit
Tampa, Florida, United States - Washington University Division of Allergy and Immunology
Saint Louis, Missouri, United States - (and 7 more...)
|
| 10 |
NCT01275976 |
Terminated |
Effect of C1-esterase Inhibitor on Systemic Inflammation in Trauma Patients With a Femur or Pelvic Fracture |
- Trauma
- Inflammation
- Sepsis
- Multiple Organ Dysfunction Syndrome
|
- Drug: C1-esterase inhibitor
- Other: Saline 0.9%
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Delta Interleukine-6
- Cytokines and other markers of inflammation
- Neutrophil redistribution and phenotype
- (and 2 more...)
|
11 |
All |
18 Years to 80 Years (Adult, Senior) |
NCT01275976 |
34932 |
CAESAR |
April 2012 |
February 2015 |
February 2015 |
January 13, 2011 |
February 4, 2015 |
|
- University Medical Centre Utrecht
Utrecht, Netherlands
|
| 11 |
NCT01766414 |
Completed |
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia - VECTOR II |
- Innate Immune Response
- Endotoxemia
- Inflammation
- Sepsis
|
- Drug: C1-esterase inhibitor
- Drug: Endotoxin
|
Interventional |
Phase 3 |
- Radboud University
- UMC Utrecht
- Sanquin
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Basic Science
|
- Neutrophil phenotype and redistribution
- Cytokines and other markers of inflammation
- C1-inhibitor and complement concentration and activity
|
20 |
Male |
18 Years to 35 Years (Adult) |
NCT01766414 |
36688
2011-002222-46 |
VECTORII |
September 2013 |
October 2013 |
January 2014 |
January 11, 2013 |
December 2, 2014 |
|
- Radboud University
Nijmegen, Netherlands
|
| 12 |
NCT00785018 |
Completed |
In Vivo Effects of C1-esterase Inhibitor on the Innate Immune Response During Human Endotoxemia |
- Endotoxemia
- Inflammation
- Multi Organ Dysfunction Syndrome
|
- Drug: C1-esterase inhibitor
- Drug: Endotoxin administration
|
Interventional |
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Basic Science
|
- Cytokines and other markers of Inflammation
- Neutrophil redistribution and phenotype
- C1-inhibitor and complement concentration and activity
- (and 2 more...)
|
20 |
Male |
18 Years to 35 Years (Adult) |
NCT00785018 |
VECTOR study 2008/197 |
VECTOR |
November 2008 |
December 2008 |
August 2009 |
November 5, 2008 |
April 22, 2011 |
|
- Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
|
| 13 |
NCT00225147 |
Completed
Has Results |
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema |
- Hereditary Angioedema
- Angioneurotic Edema
|
- Drug: Recombinant Human C1 Inhibitor
- Drug: placebo
|
Interventional |
Phase 2
Phase 3 |
- Pharming Technologies B.V.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to Beginning of Relief of Symptoms
- Time to Minimal Symptoms
|
77 |
All |
12 Years and older (Child, Adult, Senior) |
NCT00225147 |
C1 1205-01 |
|
July 2005 |
October 2009 |
January 2010 |
September 23, 2005 |
February 22, 2013 |
August 31, 2012 |
- For information on sites please contact Pharming Medical Affairs Department
Leiden, Netherlands
|
| 14 |
NCT00851409 |
Completed
Has Results |
A Study of the Safety and Immunogenicity of Repeated rhC1INH Administration |
- Genetic Disorders
- Hereditary Angioedema
|
- Drug: Recombinant Human C1 Inhibitor
|
Interventional |
Phase 2 |
- Pharming Technologies B.V.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HAE Attacks/Week
- The Evaluation of Pharmacokinetic/ Pharmacodynamic ("PK/PD")Parameters.
|
25 |
All |
18 Years and older (Adult, Senior) |
NCT00851409 |
C1 1207 |
OPERA |
June 2009 |
March 2010 |
April 2010 |
February 26, 2009 |
January 31, 2013 |
January 31, 2013 |
- For information on sites, please contact Pharming Technologies
Leiden, Netherlands - Emergency County Hospital, Internal Medicin Clinica, Allergology-Immunology Department
Tirgu Mures, Romania
|
| 15 |
NCT00262301 |
Completed
Has Results |
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema |
- Hereditary Angioedema
- Angioneurotic Edema
- Genetic Disorders
|
- Drug: recombinant human C1 inhibitor
- Drug: Placebo
|
Interventional |
Phase 3 |
- Pharming Technologies B.V.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to Beginning of Relief of Symptoms
- Time to Minimal Symptoms
|
75 |
All |
16 Years and older (Child, Adult, Senior) |
NCT00262301 |
C1 1304-01 |
|
June 2004 |
July 2009 |
October 2009 |
December 6, 2005 |
October 2, 2012 |
August 30, 2012 |
- For information on sites, please contact Pharming Medical Affairs Deparment
Leiden, Netherlands - Emergency County Hospital, Internal Medicin Clinica, Allergology-Immunology Department
Tirgu Mures, Romania
|
| 16 |
NCT01397864 |
Recruiting |
C1 Inhibitor Registry in the Treatment of Hereditary Angioedema (HAE) Attacks |
|
|
Observational |
|
- Pharming Technologies B.V.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- The primary objective is to observe the adverse event profile and insufficient efficacy, following single and repeated treatment with Ruconest or pdC1INHof acute angioedema attacks
- To assess the immunological profile of Ruconest (for suspected hypersensitivity or suspected neutralizing antibodies)
|
300 |
All |
Child, Adult, Senior |
NCT01397864 |
C1 1412 |
|
July 2011 |
December 2019 |
June 2020 |
July 20, 2011 |
April 4, 2018 |
|
- UMHAT Alexandrovska EAD
Sofia, Bulgaria - Faculty Hospital by St. Anna Brno
Brno, Czechia - Hospital A Michallon, CHU Grenoble
La Tronche, France - (and 10 more...)
|
| 17 |
NCT00262288 |
Completed |
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema |
|
- Drug: i.v. recombinant human C1 inhibitor
|
Interventional |
Phase 2
Phase 3 |
- Pharming Technologies B.V.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary outcomes: Relief of angioedema symptoms
- Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics
|
14 |
All |
16 Years to 70 Years (Child, Adult, Senior) |
NCT00262288 |
C1 1203-01 |
|
April 2004 |
January 2007 |
January 2007 |
December 6, 2005 |
February 22, 2013 |
|
- For information on sites in Europe, please contact Pharming Technologies.
Leiden, Netherlands
|
| 18 |
NCT00261053 |
Completed |
Recombinant Human C1 Inhibitor for the Treatment of Acute Attacks in Patients With Hereditary Angioedema |
|
- Drug: i.v. recombinant human C1 inhibitor
|
Interventional |
Phase 2 |
- Pharming Technologies B.V.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Primary outcomes: Relief of angioedema symptoms
- Secondary outcomes: Safety and tolerability; pharmacokinetics/pharmacodynamics
|
14 |
All |
18 Years to 65 Years (Adult) |
NCT00261053 |
C1 1202-01 |
|
June 2003 |
September 2005 |
December 2005 |
December 2, 2005 |
April 25, 2013 |
|
- For information contact Sonja Visscher
Leiden, Netherlands
|
| 19 |
NCT01576523 |
Completed |
A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route |
- Hereditary Angioedema Types I and II
|
- Biological: C1-esterase inhibitor - single intravenous dose
- Biological: C1-esterase inhibitor - subcutaneous low dose
- Biological: C1-esterase inhibitor - subcutaneous medium dose
- Biological: C1-esterase inhibitor - subcutaneous high dose
|
Interventional |
Phase 1
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Modeled C1-esterase inhibitor functional activity trough level
- C1-esterase inhibitor functional activity trough level
- C1-esterase inhibitor concentration trough level
- (and 4 more...)
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT01576523 |
CSL830_2001
2011-005013-36 |
|
April 2012 |
December 2012 |
December 2012 |
April 12, 2012 |
July 28, 2017 |
|
- Study Site
Atlanta, Georgia, United States - Study Site
Chevy Chase, Maryland, United States - Study Site
Cincinnati, Ohio, United States - (and 5 more...)
|
| 20 |
NCT00168103 |
Completed
Has Results |
Human C1 Esterase Inhibitor (C1-INH) in Subjects With Acute Abdominal or Facial Hereditary Angioedema (HAE) Attacks |
|
- Biological: C1 Esterase Inhibitor
- Biological: Placebo
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Time to Start of Relief of Symptoms From HAE Attack
- Number of Subjects With Worsened Intensity of Clinical HAE Symptoms
- Number of Vomiting Episodes
|
126 |
All |
6 Years and older (Child, Adult, Senior) |
NCT00168103 |
CE1145_3001
2004-001186-17 |
|
June 2005 |
October 2007 |
December 2007 |
September 14, 2005 |
March 31, 2015 |
August 24, 2010 |
- Study Site
Granada Hills, California, United States - Study Site
Weston, Florida, United States - Study Site
Atlanta, Georgia, United States - (and 33 more...)
|
| 21 |
NCT03221842 |
Recruiting |
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 |
- Antibody-mediated Rejection
|
- Drug: C1-esterase inhibitor
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Sequential Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Time to loss of response during Treatment Period 2
- Time to all-cause allograft failure through the follow-up period for both Treatment Period 1 responders and non-responders
- Percentage of subjects with response to treatment at the end of Treatment Period 1
- (and 9 more...)
|
90 |
All |
18 Years and older (Adult, Senior) |
NCT03221842 |
CSL842_3001
2017-000348-17 |
|
November 6, 2017 |
July 16, 2020 |
October 16, 2023 |
July 19, 2017 |
March 20, 2018 |
|
- University of Alabama Hospital (at Birmingham)
Birmingham, Alabama, United States - California Pacific
San Francisco, California, United States - Yale New Haven Hospital
New Haven, Connecticut, United States - (and 26 more...)
|
| 22 |
NCT01759602 |
Completed
Has Results |
C1-esterase Inhibitor (Cinryze) for Acute Treatment of Neuromyelitis Optica Exacerbation |
|
- Drug: C1-esterase inhibitor (Cinryze)
|
Interventional |
Phase 1 |
- Michael Levy
- ViroPharma
- Johns Hopkins University
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Adverse Safety Events During Hospitalization
- Frequency of Serious Adverse Events.
- Percentage of Subjects Withdrawing Due to Adverse Events.
- (and 2 more...)
|
10 |
All |
18 Years to 65 Years (Adult) |
NCT01759602 |
NA_00078437 |
|
January 2013 |
November 2013 |
November 2013 |
January 3, 2013 |
July 18, 2014 |
July 18, 2014 |
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
| 23 |
NCT02584959 |
Completed |
Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1 Esterase Inhibitor for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema |
- Hereditary Angioedema (HAE)
|
- Drug: C1 esterase inhibitor [human] liquid
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Time-Normalized Number of Attacks (NNA) for participants
- Proportion of subjects meeting at least a 50% reduction in the NNA during the experimental injection treatment period relative to the placebo period.
- Cumulative attack severity
- (and 5 more...)
|
66 |
All |
12 Years and older (Child, Adult, Senior) |
NCT02584959 |
SHP616-300 |
|
November 1, 2015 |
July 24, 2017 |
July 24, 2017 |
October 23, 2015 |
September 6, 2017 |
|
- Medical Research of Arizona
Scottsdale, Arizona, United States - AIRE Medical of Los Angeles
Santa Monica, California, United States - Bay Area Allergy
Walnut Creek, California, United States - (and 24 more...)
|
| 24 |
NCT00914966 |
Completed
Has Results |
A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE |
|
- Biological: C1 inhibitor (human) [C1 INH]
|
Interventional |
Phase 4 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Number of Subjects With Adverse Events, Hospitalizations, Thrombotic Events, Treatment-emergent C1 INH Antibodies, Post-baseline Toxicity Grade Increases in Clinical Laboratory Parameters, and Post-dose Vital Signs Changes of Potential Clinical Importance
- Treatment Effect of Escalating Doses of CINRYZE on HAE Attack Rates
- Use of Rescue Therapy and/or Other Therapy for Treatment of HAE Symptoms
|
20 |
All |
6 Years and older (Child, Adult, Senior) |
NCT00914966 |
0624-400 |
|
July 2009 |
May 2012 |
May 2012 |
June 5, 2009 |
April 15, 2014 |
July 18, 2013 |
- Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, United States - Family Allergy and Asthma Center
Atlanta, Georgia, United States - Institute for Asthma and Allergy
Wheaton, Maryland, United States - (and 8 more...)
|
| 25 |
NCT01147302 |
Completed
Has Results |
A Pilot Study to Evaluate the Use of C1 Esterase Inhibitor (Human) in Patients With Acute Antibody-Mediated Rejection |
|
- Biological: Placebo
- Biological: C1 Esterase Inhibitor (Human)
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline in Histopathology Endpoints
- Number of Participants With Resolution of The Qualifying Episode of Antibody-Mediated Rejection (AMR)
- Change From Baseline in Serum Creatinine
- (and 10 more...)
|
18 |
All |
18 Years and older (Adult, Senior) |
NCT01147302 |
0624-201
2012-000441-12 |
|
November 2010 |
April 2013 |
June 2013 |
June 22, 2010 |
August 13, 2015 |
July 9, 2015 |
- ViroPharma Investigative Site
Los Angeles, California, United States - ViroPharma Investigative Site
Baltimore, Maryland, United States - ViroPharma Investigative Site
Minneapolis, Minnesota, United States - (and 2 more...)
|
| 26 |
NCT00438815 |
Completed
Has Results |
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks |
|
- Biological: C1 esterase inhibitor [human] (C1INH-nf)
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Hereditary Angioedema (HAE) Attacks Treated With C1INH-nf
- Percent of HAE Attacks With Substantial Relief of the Defining Symptom
- Time to Beginning of Substantial Relief of the Defining Symptom
- (and 4 more...)
|
113 |
All |
1 Year and older (Child, Adult, Senior) |
NCT00438815 |
LEVP2006-1 |
CHANGE 2 |
September 2006 |
March 2009 |
March 2009 |
February 22, 2007 |
April 15, 2014 |
June 9, 2010 |
- Allergy and Immunology Associates
Scottsdale, Arizona, United States - Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States - UCLA-David Geffen School of Medicine
Los Angeles, California, United States - (and 27 more...)
|
| 27 |
NCT01188564 |
Completed
Has Results |
Efficacy, Safety and Immunogenicity Study of Recombinant Human C1 Inhibitor for the Treatment of Acute HAE Attacks |
|
- Drug: rhC1INH
- Drug: Placebo (Saline)
|
Interventional |
Phase 3 |
- Pharming Technologies B.V.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Time to Beginning of Relief of Symptoms
- Time to Minimal Symptoms
|
75 |
All |
13 Years and older (Child, Adult, Senior) |
NCT01188564 |
C1 1310 |
|
January 2011 |
December 2012 |
March 2013 |
August 25, 2010 |
August 7, 2015 |
August 7, 2015 |
- 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 - (and 24 more...)
|
| 28 |
NCT00125151 |
Completed |
C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema |
|
- Drug: C1 inhibitor concentrate (C1-esteraseremmer-N)
|
Interventional |
Phase 3 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary objective in this clinical study, in which patients use C1-esteraseremmer-N to treat an attack of angioedema, is to investigate the efficacy and the time-to-effect of C1-esteraseremmer-N.
- Secondary objectives are the safety of C1-esteraseremmer-N and the ability of C1-esteraseremmer-N to increase the C1 inhibitor level and activity.
|
15 |
All |
16 Years and older (Child, Adult, Senior) |
NCT00125151 |
KB2003.01B |
|
February 2006 |
|
April 2007 |
July 29, 2005 |
May 4, 2009 |
|
- Academic Medical Centre
Amsterdam, Netherlands - Academic hospital Groningen
Groningen, Netherlands - Erasmus Medical Centre
Rotterdam, Netherlands
|
| 29 |
NCT01035593 |
Withdrawn |
Recombinant Human C1 Inhibitor for the Treatment of Early Antibody-Mediated Rejection in Renal Transplantation |
- Graft Rejection
- Kidney Transplantation
|
- Procedure: plasmapheresis and IVIG
- Drug: recombinant C1 inhibitor
|
Interventional |
Phase 2 |
- Pharming Technologies B.V.
- University of Wisconsin, Madison
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy will be defined as renal allograft survival 6 months following treatment for AMR. Renal allograft loss will be defined as either (1) subject death, (2) return to dialysis for greater than 30 days, or (3) re-transplantation.
|
0 |
All |
18 Years and older (Adult, Senior) |
NCT01035593 |
C1 2201 |
|
December 2010 |
December 2011 |
December 2011 |
December 18, 2009 |
February 17, 2012 |
|
- University of Wisconsin
Madison, Wisconsin, United States
|
| 30 |
NCT01912456 |
Completed |
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema |
- Hereditary Angioedema Types I and II
|
- Biological: Low-volume C1-esterase inhibitor
- Biological: Higher-volume C1-esterase inhibitor
- Biological: Low-volume placebo
- Biological: Higher-volume placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- The time-normalized number of hereditary angioedema attacks
- Percentage of subjects with a ≥ 50% reduction in the number of hereditary angioedema attacks
- Number of uses of rescue medication
- (and 4 more...)
|
90 |
All |
12 Years and older (Child, Adult, Senior) |
NCT01912456 |
CSL830_3001
2013-000916-10 |
|
January 2014 |
October 2015 |
October 2015 |
July 31, 2013 |
July 28, 2017 |
|
- Study Site
Birmingham, Alabama, United States - Study Site
Scottsdale, Arizona, United States - Study Site
Bell Gardens, California, United States - (and 36 more...)
|
| 31 |
NCT00462709 |
Completed
Has Results |
Open-Label C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks |
|
- Biological: C1 esterase inhibitor [human] (C1INH-nf)
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Frequency of All HAE Attacks
|
146 |
All |
1 Year and older (Child, Adult, Senior) |
NCT00462709 |
LEVP2006-4 |
CHANGE 3 |
June 2006 |
March 2009 |
March 2009 |
April 19, 2007 |
April 15, 2014 |
May 3, 2010 |
- Clinical Research Consultants, Inc
Hoover, Alabama, United States - Allergy and Immunology Associates
Scottsdale, Arizona, United States - Allergy and Asthma Clinic of Northwest Arkansas
Bentonville, Arkansas, United States - (and 45 more...)
|
| 32 |
NCT00432510 |
Completed |
Pharmacokinetics of C1 Esterase Inhibitor in Hereditary Angioedema Subjects |
|
- Drug: C1 esterase inhibitor [human] (C1INH-nf)
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- PK will be analyzed by means of incremental recovery, in vivo half-life, area under the curve, clearance, and mean residence time.
- C1 inhibitor (functional and antigenic) and C4 antigen serum levels will be measured at a United States Clinical Laboratory Improvement Amendments-certified laboratory and the research division of Sanquin Blood Supply Foundation.
- Number and severity of adverse events.
- (and 2 more...)
|
27 |
All |
18 Years and older (Adult, Senior) |
NCT00432510 |
LEVP2006-5 |
|
October 2006 |
March 2007 |
June 2007 |
February 8, 2007 |
March 20, 2014 |
|
- University of California, San Diego
San Diego, California, United States - Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States - Family Allergy and Asthma Center
Atlanta, Georgia, United States - (and 3 more...)
|
| 33 |
NCT02316353 |
Completed |
A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema |
- Hereditary Angioedema Types I and II
|
- Biological: C1-esterase inhibitor
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The person-time incidence rates of specified safety events
- Percentage of subjects with SAEs or other specified safety events.
- Percentage of C1-INH injections resulting in solicited AEs (injection site reactions).
- (and 4 more...)
|
126 |
All |
6 Years and older (Child, Adult, Senior) |
NCT02316353 |
CSL830_3002
2014-001054-42 |
|
December 31, 2014 |
September 21, 2017 |
September 21, 2017 |
December 12, 2014 |
March 20, 2018 |
|
- Study Site
Birmingham, Alabama, United States - Study Site
Scottsdale, Arizona, United States - Study Site
La Jolla, California, United States - (and 29 more...)
|
| 34 |
NCT02869347 |
Recruiting |
Recombinant Human C1 Esterase Inhibitor in the Prevention of Contrast-induced Nephropathy in High-risk Subjects |
|
- Drug: Conestat alfa
- Drug: Sodium chloride 0.9%
|
Interventional |
Phase 2 |
- University Hospital, Basel, Switzerland
- Pharming Technologies B.V.
- Clinical Trial Unit, University Hospital Basel, Switzerland
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Peak change from baseline of urinary Neutrophil gelatinase-associated lipocalin
- Development of contrast-induced nephropathy
- Cystatin C increase of at least 10%
- (and 2 more...)
|
80 |
All |
18 Years and older (Adult, Senior) |
NCT02869347 |
BASEC 2016-01112 |
PROTECT |
January 2017 |
May 2018 |
May 2018 |
August 16, 2016 |
March 7, 2018 |
|
- University Hospital Basel
Basel, BS, Switzerland
|
| 35 |
NCT00119431 |
Completed |
Kinetics, Efficacy and Safety of C1-Esteraseremmer-N |
- Hereditary Angioedema Type I
- Angioneurotic Edema
|
- Drug: C1 inhibitor concentrate
|
Interventional |
Phase 2 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double
- Primary Purpose: Prevention
|
- Pharmacokinetics of C1-esteraseremmer-N versus Cetor.
- Laboratory and clinical safety as well as clinical tolerance of C1-esteraseremmer-N versus current Cetor.
|
12 |
All |
18 Years and older (Adult, Senior) |
NCT00119431 |
KB2003.01A |
|
September 2005 |
|
March 2006 |
July 13, 2005 |
May 4, 2009 |
|
- Academic Medical Centre
Amsterdam, Netherlands - Erasmus Medical Centre
Rotterdam, Netherlands
|
| 36 |
NCT00125541 |
Completed |
C1-Esteraseremmer-N for the Treatment of Hereditary (and Acquired) Angioedema |
|
- Drug: C1 inhibitor concentrate (C1-esteraseremmer-N)
|
Interventional |
Phase 2
Phase 3 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- The primary objective in this clinical study is to evaluate the prevention of angioedema attacks in patients prophylactically treated with C1-esteraseremmer-N.
- The secondary objective of this study is to evaluate the safety and clinical activity of C1-esteraseremmer-N.
|
6 |
All |
16 Years and older (Child, Adult, Senior) |
NCT00125541 |
KB2003.01C |
|
November 2006 |
April 2008 |
May 2008 |
August 1, 2005 |
May 4, 2009 |
|
- Academic Medical Centre
Amsterdam, Netherlands
|
| 37 |
NCT01095510 |
Completed
Has Results |
CINRYZE for the Treatment of Hereditary Angioedema Attacks in Children Under the Age of 12 |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Presence of Unequivocal Beginning of Relief of the Defining Attack Symptom
- Time to Unequivocal Beginning of Relief of the Defining Attack Symptom
- Time to Complete Resolution of the Attack
- Change in C1 Inhibitor (C1 INH) Antigen and Functional C1 INH Concentrations
|
9 |
All |
2 Years to 11 Years (Child) |
NCT01095510 |
0624-203
2011-000369-11 |
|
March 2010 |
June 2013 |
June 2013 |
March 30, 2010 |
August 5, 2015 |
July 25, 2014 |
- Asthma & Allergy Associates, P.C.
Colorado Springs, Colorado, United States - University of South Florida Asthma, Allergy and Immunology Clinical Research Unit
Tampa, Florida, United States - Institute for Asthma and Allergy, PC
Chevy Chase, Maryland, United States - (and 8 more...)
|
| 38 |
NCT01843530 |
Recruiting |
Randomized, Double-blind, Two Arms, Multicenter, Phase III Study of Berinert for Treatment of ACE Induced Angioedema |
- Acute ACE-induced Angioedema
|
- Drug: Berinert
- Drug: Clemastin
- Drug: Cortisone acetate
- Drug: NaCl
|
Interventional |
Phase 3 |
- Technische Universität München
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
31 |
All |
18 Years and older (Adult, Senior) |
NCT01843530 |
BER-1272-0058-I |
|
November 2013 |
January 2018 |
September 2018 |
April 30, 2013 |
April 29, 2016 |
|
- Charite, Universitätsmedizin Berlin, Campus Virchow Kliniken
Berlin, Germany - Kath. Klinikum Bochum, Med. Klinik III
Bochum, Germany - Ludwig-Maximilian-Universität
München, Germany - (and 2 more...)
|
| 39 |
NCT01005888 |
Completed
Has Results |
C1 Esterase Inhibitor (C1INH-nf) for the Prevention of Acute Hereditary Angioedema (HAE) Attacks |
|
- Biological: C1 esterase inhibitor [human] (C1INH-nf)
- Drug: Placebo (saline)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Number of Hereditary Angioedema (HAE) Attacks During Each Prophylactic Therapy Period
- Number of Subject Withdrawals During Each Prophylactic Therapy Period
- Average Severity of HAE Attacks During Each Prophylactic Therapy Period
- (and 4 more...)
|
26 |
All |
6 Years and older (Child, Adult, Senior) |
NCT01005888 |
LEVP2005-1/Part B |
|
September 2005 |
May 2007 |
August 2007 |
November 2, 2009 |
April 15, 2014 |
June 3, 2010 |
- Allergy and Immunology Associates
Scottsdale, Arizona, United States - University of California, San Diego
San Diego, California, United States - Allergy and Asthma Clinical Research, Inc
Walnut Creek, California, United States - (and 13 more...)
|
| 40 |
NCT02936479 |
Enrolling by invitation |
C1-INH for Refractory Antibody Mediated Renal Allograft Rejection |
- Antibody Mediated Rejection of Kidney Transplant
|
|
Interventional |
Phase 2 |
- New York University School of Medicine
- CSL Behring
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
5 |
All |
18 Years to 70 Years (Adult, Senior) |
NCT02936479 |
16-01851 |
|
October 2016 |
October 2021 |
October 2021 |
October 18, 2016 |
November 9, 2017 |
|
- New York University School of Medicine
New York, New York, United States
|
| 41 |
NCT00289211 |
Completed
Has Results |
C1 Esterase Inhibitor (C1INH-nf) for the Treatment of Acute Hereditary Angioedema (HAE) Attacks |
|
- Biological: C1 esterase inhibitor [human] (C1INH-nf)
- Drug: Placebo (saline)
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Time to Beginning of Substantial Relief of the Defining Symptom
- Number of Subjects With Beginning of Substantial Relief of the Defining Symptom
- Time to Complete Resolution of the HAE Attack
- (and 3 more...)
|
83 |
All |
6 Years and older (Child, Adult, Senior) |
NCT00289211 |
LEVP2005-1/Part A |
|
June 2005 |
December 2006 |
September 2007 |
February 9, 2006 |
April 15, 2014 |
June 2, 2010 |
- Clinical Research Consultants, Inc
Hoover, Alabama, United States - Allergy and Immunology Associates
Scottsdale, Arizona, United States - UCLA-David Geffen School of Medicine
Los Angeles, California, United States - (and 34 more...)
|
| 42 |
NCT02865720 |
Completed |
Study of C1 Inhibitor (Human) for the Prevention of Angioedema Attacks and Treatment of Breakthrough Attacks in Japanese Subjects With Hereditary Angioedema (HAE) |
- Hereditary Angioedema (HAE)
|
- Drug: CINRYZE 500 U
- Drug: CINRYZE 1000 U
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety and tolerability of CINRYZE administered by intravenous (IV) as measured by adverse events and changes in physical examinations, vital signs, and clinical safety laboratory testing
- Pharmacokinetics (PK) of CINRYZE as measured by Concentrations of C1 INH antigen (protein volume)
- Treatment effect of CINRYZE administered by IV infusion for the prevention
- (and 2 more...)
|
8 |
All |
2 Years and older (Child, Adult, Senior) |
NCT02865720 |
SHP616-209
0624-209 |
|
September 8, 2016 |
June 23, 2017 |
June 23, 2017 |
August 12, 2016 |
March 6, 2018 |
|
- Toyohashi Municipal Hospital
Toyohashi, Aiti, Japan - Gunma University Hospital
Maebashi, Gunma, Japan - Kobe University Hospital
Kobe, Hyogo, Japan - (and 7 more...)
|
| 43 |
NCT01694381 |
Suspended |
Research Into the Effect of a Clot-dissolving Agent and Its Inhibitor |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Changes to vital signs, routine safety laboratory results, or ECG-findings
|
50 |
Male |
18 Years to 35 Years (Adult) |
NCT01694381 |
TS01-01
2012-002225-30 |
|
September 2015 |
December 2015 |
December 2015 |
September 27, 2012 |
January 13, 2015 |
|
- Center for Human Drug Research
Leiden, Netherlands
|
| 44 |
NCT01426763 |
Completed
Has Results |
A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase |
|
- Biological: CINRYZE with rHuPH20
|
Interventional |
Phase 2 |
- Shire
- Halozyme Therapeutics
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study
- C1 Inhibitor (C1 INH) and C4 Levels
- Number of Subjects With C1 INH Antibodies
|
12 |
All |
12 Years and older (Child, Adult, Senior) |
NCT01426763 |
0624-204 |
|
September 2011 |
November 2011 |
November 2011 |
August 31, 2011 |
April 15, 2014 |
January 4, 2013 |
- ViroPharma Investigational Site
Scottsdale, Arizona, United States - ViroPharma Investigational Site
Walnut Creek, California, United States - ViroPharma Investigational Site
Atlanta, Georgia, United States - ViroPharma Investigational Site
Dallas, Texas, United States
|
| 45 |
NCT01359969 |
Recruiting |
Safety of Ruconest in 2-13 Year Old Hereditary Angioedema (HAE) Patients |
|
|
Interventional |
Phase 2 |
- Pharming Technologies B.V.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The primary objective is the assessment of safety and tolerability (adverse events, physical examination, vital signs, immunological and routine laboratory analyses et cetera)
- Immunogenicity by assessing antibodies against recombinant human C1INH (IgG and IgM) anti-rhC1INH)
- Immunogenicity by assessing antibodies against host related impurities (anti-HRI)
- (and 6 more...)
|
20 |
All |
2 Years to 13 Years (Child) |
NCT01359969 |
C1 1209
2011-000987-92 |
|
December 2011 |
December 2017 |
December 2017 |
May 25, 2011 |
October 17, 2016 |
|
- UIA FN Plzen ( Institute of Immunology and Allergology), Faculty Hospital Plzen
Plzen, Alej Svobody 80, Czechia - University Hospital Motol, Institute of Immunology
Prague, V Úvalu 84, Czechia - Charité - Universitätsmedizin Berlin
Berlin, Charitéplatz 1, Germany - (and 12 more...)
|
| 46 |
NCT02663687 |
Completed |
Phase 1 Study to Assess the Safety, Tolerability, and Pharmacokinetics of Recombinant Human C1 Esterase Inhibitor in Healthy Adult Subjects |
- Hereditary Angioedema (HAE)
|
- Drug: Recombinant human C1 esterase inhibitor
- Drug: Placebo
- Drug: SHP623
|
Interventional |
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of participants with treatment-emergent adverse events (TEAEs ) including SAEs
- Maximum concentration occurring at tmax (Cmax) of IV SHP623
- Time to reach the maximum plasma concentration (Tmax) of IV SHP623
- (and 14 more...)
|
48 |
All |
18 Years to 50 Years (Adult) |
NCT02663687 |
SHP623-100 |
|
April 2016 |
December 2016 |
December 2016 |
January 26, 2016 |
December 12, 2016 |
|
- Clinical Pharmacology of Miami
Miami, Florida, United States
|
| 47 |
NCT02833675 |
Completed |
Determination of Specific Biomarkers of Angioneurotic Crisis |
|
|
Observational |
|
- University Hospital, Grenoble
|
Other |
- Observational Model: Case-Control
- Time Perspective: Prospective
|
- VE CADHERIN SENSITIVITY AND SPECIFICITY
- D-DIMERS SENSITIVITY AND SPECIFICITY
- C1INHIBITOR
|
120 |
All |
18 Years and older (Adult, Senior) |
NCT02833675 |
38RC12.210 |
BIOBRAD |
October 2012 |
August 2017 |
September 2017 |
July 14, 2016 |
September 29, 2017 |
|
- Grenoble university hospital
Grenoble, France
|
| 48 |
NCT01756157 |
Completed
Has Results |
Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks |
|
- Biological: CINRYZE with rHuPH20
|
Interventional |
Phase 2 |
- Shire
- Halozyme Therapeutics
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Normalized Number of Angioedema Attacks During the Treatment Period
- Cumulative Attack-severity During the Treatment Period
- Cumulative Daily-severity During the Treatment Period
- (and 2 more...)
|
47 |
All |
12 Years and older (Child, Adult, Senior) |
NCT01756157 |
0624-206
2012-000083-24 |
|
December 2012 |
August 2013 |
September 2013 |
December 25, 2012 |
June 12, 2015 |
June 12, 2015 |
- ViroPharma Investigational Site
Birmingham, Alabama, United States - ViroPharma Investigational Site
Scottsdale, Arizona, United States - ViroPharma Investigational Site
Bentonville, Arkansas, United States - (and 20 more...)
|
| 49 |
NCT01095497 |
Completed
Has Results |
A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration |
|
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
|
- Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study.
- C1 Inhibitor (C1INH) and C4 Levels
- Number of Subjects With C1INH Antibodies
|
26 |
All |
12 Years and older (Child, Adult, Senior) |
NCT01095497 |
0624-200 |
|
May 2010 |
December 2010 |
December 2010 |
March 30, 2010 |
May 9, 2014 |
March 8, 2012 |
- Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, United States - Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States - Family Allergy and Asthma Center
Atlanta, Georgia, United States - (and 4 more...)
|
| 50 |
NCT02052141 |
Completed |
Safety and Efficacy Study of CINRYZE for Prevention of Angioedema Attacks in Children Ages 6-11 With Hereditary Angioedema |
- Hereditary Angioedema (HAE)
|
- Biological: CINRYZE 500
- Biological: CINRYZE 1000
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Number of angioedema attacks in each treatment period
- Number of subjects with adverse events by dose group
- Change from baseline in C1 inhibitor (C1 INH) and C4 concentrations during each treatment period
- Number of subjects with C1 INH antibodies
|
12 |
All |
6 Years to 11 Years (Child) |
NCT02052141 |
0624-301
2013-002453-29
SHP616-301 |
|
March 20, 2014 |
May 5, 2017 |
May 5, 2017 |
January 31, 2014 |
May 25, 2017 |
|
- Asthma and Allergy Associates, P.C
Colorado Springs, Colorado, United States - Nevada Access to Research and Education Society
Las Vegas, Nevada, United States - Oregon Allergy Associates
Eugene, Oregon, United States - (and 5 more...)
|
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