Clinical trials: sponsored by CSL Behring
- Lead sponsor (exact) CSL Behring
- Funder type Industry (pharma, biotech, devices)
- Has posted results yes
Graft Versus Host Disease (GVHD)
Treatment of GVHD in Hematopoietic Stem Cell Transplant (HSCT) Recipients Using AAT Plus Corticosteroids (CS) Compared With Corticosteroids Alone
Study CSL964_5001 will investigate the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD
- Trial name
- NCT04167514
- Testing
- Alpha-1 antitrypsin (AAT)
- Where
- 25 sites in United States
- Volunteers
- 136 people
- Sponsor
- CSL Behring
Hereditary Angioedema
Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks
This phase 3b study will evaluate long-term safety and efficacy of CSL312 (also known as garadacimab) when administered subcutaneously (SC)
- Trial name
- NCT04739059
- Testing
- CSL312
- Where
- 44 sites in United States, Australia and 12 more
- Volunteers
- 171 people
- Sponsor
- CSL Behring
Hereditary Angioedema (HAE)
CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema
The purpose of this study is to investigate the safety, PK / PD, and efficacy of SC CSL312 for prophylactic treatment of pediatric subjects with HAE.
- Trial name
- NCT05819775
- Testing
- CSL312
- Where
- 13 sites in United States, Australia and 3 more
- Volunteers
- 22 people
- Sponsor
- CSL Behring
Post-COVID Postural Orthostatic Tachycardia Syndrome
Double-blind, Randomized, Placebo-controlled Study Evaluating Efficacy and Safety of IgPro20 in Post-COVID-19 POTS
This is a prospective, phase 3, multicenter, double-blind, randomized placebo-controlled study to investigate the efficacy, safety, and pharmacokinetics (PK) of repeat doses of IgPro20 in participants with post SARS-CoV-2…
- Trial name
- NCT06524739
- Testing
- IgPro20
- Where
- 38 sites in United States, Canada
- Volunteers
- 16 people
- Sponsor
- CSL Behring
Hemophilia B
HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients
This is an open-label, single-dose, multi-center, multinational trial to demonstrate the efficacy of AMT-061 and to further describe its safety profile. The study drug is identified as AAV5-hFIXco-Padua (AMT- 061).
- Trial name
- NCT03569891
- Testing
- AAV5-hFIXco-Padua, Factor IX (FIX)
- Where
- 33 sites in United States, Belgium and 6 more
- Volunteers
- 67 people
- Sponsor
- CSL Behring
Traumatic Injury
Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study )
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, parallel-group, large simple trial to investigate the efficacy and safety of a single intravenous (IV) infusion of BE1116 in subjects who have…
- Trial name
- NCT05568888
- Testing
- BE1116
- Where
- 113 sites in United States, Australia and 1 more
- Volunteers
- 1,366 people
- Sponsor
- CSL Behring
Dermatomyositis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults With Dermatomyositis (DM)
This is a phase 3, multicenter, randomized, placebo-controlled, double-blind study of IgPro20 (subcutaneous Ig) treatment in adult subjects with dermatomyositis (DM).
- Trial name
- RECLAIIM (NCT04044690)
- Testing
- human immunoglobulin G
- Where
- 76 sites in United States, Argentina and 12 more
- Volunteers
- 134 people
- Sponsor
- CSL Behring
Antibody-mediated Rejection
Clazakizumab for the Treatment of Chronic Active Antibody Mediated Rejection in Kidney Transplant Recipients
This trial investigates the efficacy and safety of clazakizumab [an anti-interleukin (IL)-6 monoclonal antibody (mAb)] for the treatment of CABMR in recipients of a kidney transplant.
- Trial name
- IMAGINE (NCT03744910)
- Testing
- Clazakizumab, Physiologic saline solution
- Where
- 142 sites in United States, Australia and 13 more
- Volunteers
- 194 people
- Sponsor
- CSL Behring
Acute Coronary Syndrome
Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome
This is a phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of CSL112 on reducing the risk of major adverse CV events [MACE - cardiovascular (CV) death…
- Trial name
- AEGIS-II (NCT03473223)
- Testing
- Apolipoprotein A-I [human] (apoA-I)
- Where
- 903 sites in United States, Argentina and 47 more
- Volunteers
- 18,226 people
- Sponsor
- CSL Behring
Idiopathic Pulmonary Fibrosis
Garadacimab Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis
This is a prospective, phase 2a, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to assess the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of garadacimab in subjects with idiopathic…
- Trial name
- NCT05130970
- Testing
- Garadacimab
- Where
- 47 sites in United States, Australia and 9 more
- Volunteers
- 81 people
- Sponsor
- CSL Behring
Hemophilia B
Dose Confirmation Trial of AAV5-hFIXco-Padua
This is an open-label, single-dose, single-arm, multi-center trial, with a screening, a treatment + post-treatment follow-up phase, and a long-term follow-up phase.
- Trial name
- NCT03489291
- Testing
- AAV5-hFIXco-Padua (AMT-061)
- Where
- 4 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
Chronic Inflammatory Demyelinating Polyneuropathy
Study of Efficacy and Safety of Privigen in Subjects With Chronic Inflammatory Demyelinating Polyneuropathy
The objective of this study is to demonstrate the efficacy and safety of Privigen in subjects with CIDP.
- Trial name
- NCT01184846
- Testing
- 10% liquid formulation of human immunoglobulin
- Where
- 22 sites in Belgium, Finland and 3 more
- Volunteers
- 31 people
- Sponsor
- CSL Behring
Diffuse Cutaneous Systemic Sclerosis
Safety and Pharmacokinetics of IgPro20 and IgPro10 in Adults With Systemic Sclerosis (SSc)
This is a prospective, multicenter, randomized, open-label, crossover study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in participants with diffuse cutaneous systemic sclerosis (dcSSc).
- Trial name
- NCT04137224
- Testing
- IgPro20, IgPro10
- Where
- 9 sites in Australia, Germany and 3 more
- Volunteers
- 27 people
- Sponsor
- CSL Behring
Diabetic Kidney Disease (DKD)
Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease
This phase 2a, double-blind, randomized, placebo-controlled study will assess the efficacy, safety, tolerability, and pharmacokinetics (PK), of repeat doses of CSL346 in subjects with diabetic kidney disease (DKD) and albuminuria…
- Trial name
- NCT04419467
- Testing
- CSL346
- Where
- 37 sites in United States, Australia and 4 more
- Volunteers
- 114 people
- Sponsor
- CSL Behring
Hereditary Angioedema
CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
This is a multicenter, double-blind, randomized, placebo-controlled, parallel-arm study to investigate the efficacy and safety of subcutaneous administration of CSL312 (garadacimab) in the prophylactic treatment of hereditary…
- Trial name
- NCT04656418
- Testing
- CSL312
- Where
- 28 sites in United States, Canada and 5 more
- Volunteers
- 64 people
- Sponsor
- CSL Behring
Hereditary Angioedema
A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE)
This is a multicenter, randomized, placebo-controlled, parallel-arm, phase 2 study to investigate the clinical efficacy, pharmacokinetics, and safety of CSL312 as prophylaxis to prevent attacks in subjects with HAE.
- Trial name
- NCT03712228
- Testing
- Factor XIIa antagonist monoclonal antibody
- Where
- 16 sites in United States, Australia and 3 more
- Volunteers
- 44 people
- Sponsor
- CSL Behring
Antibody-mediated Rejection
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
This is a double-blind, randomized-withdrawal, placebo-controlled study in kidney transplant patients with AMR to evaluate the efficacy and safety of human plasma-derived C1-esterase inhibitor as add-on to standard of care (IVIG).
- Trial name
- NCT03221842
- Testing
- C1-esterase inhibitor
- Where
- 26 sites in United States, Belgium and 5 more
- Volunteers
- 63 people
- Sponsor
- CSL Behring
Hemophilia B
A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B
This study will examine the long-term safety and efficacy of rIX-FP for the control and prevention of bleeding episodes in children and adults with severe hemophilia B.
- Trial name
- NCT02053792
- Testing
- rIX-FP
- Where
- 42 sites in United States, Australia and 13 more
- Volunteers
- 97 people
- Sponsor
- CSL Behring
Hemophilia B
Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B
This study evaluates how safe gene therapy treatment with AAV5-hFIX is in adult patients with severe or moderately severe hemophilia B and severe bleeding type.
- Trial name
- NCT02396342
- Testing
- AAV5-hFIX
- Where
- 7 sites in Denmark, Germany and 1 more
- Volunteers
- 10 people
- Sponsor
- CSL Behring
Coronavirus Disease 2019 (COVID-19)
Treatment With CSL312 in Adults With Coronavirus Disease 2019 (COVID-19)
This is a prospective, phase 2, multicenter, randomized, double blind, placebo controlled, parallel group study to assess the safety and efficacy of CSL312 administered intravenously, in combination with standard of care (SOC)…
- Trial name
- NCT04409509
- Testing
- Garadacimab, Factor XIIa Antagonist Monoclonal Antibody
- Where
- 14 sites in United States
- Volunteers
- 124 people
- Sponsor
- CSL Behring