Clinical trials: sponsored by CSL Behring
Noncystic Fibrosis Bronchiectasis (NCFB)
Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)
This study is a prospective, multicenter, randomized, double-blind, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and exploratory efficacy of nebulized CSL787 after…
- Trial name
- NCT04643587
- Testing
- CSL787
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- 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
Healthy Volunteers
Effects of CSL324 in the Lung After Segmental Challenge
This is a phase 1b, randomized, double-blind, placebo-controlled study in healthy volunteers to investigate the antiinflammatory effect of pretreatment with CSL324 on response to a lipopolysaccharide (LPS) endotoxin challenge in…
- Trial name
- NCT05653713
- Testing
- CSL324
- Where
- Germany
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Immune Complex-mediated Autoimmune Diseases
Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects
This phase 1, randomized, double-blind, placebo-controlled study will assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of single ascending doses of CSL730 administered by subcutaneous (SC)…
- Trial name
- NCT04446000
- Testing
- CSL730
- Where
- United Kingdom
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Sickle Cell Disease
Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease
This is a phase 1, first-in-human, multi-center, open-label, single dose cohort study to evaluate the safety and tolerability, pharmacokinetics (PK), exploratory pharmacodynamics (PD), and biomarkers of target engagement of…
- Trial name
- NCT04285827
- Testing
- CSL889
- Where
- 15 sites in United States, Netherlands and 1 more
- Volunteers
- 28 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
Hidradenitis Suppurativa, Palmoplantar Pustulosis
Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis
Study CSL324_1002 will investigate the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis.
- Trial name
- NCT03972280
- Testing
- Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
- Where
- 11 sites in Australia, Denmark and 1 more
- Volunteers
- 39 people
- Sponsor
- CSL Behring
Antibody-mediated Rejection in Kidney Transplant
Assess Burden of Disease Among Kidney Transplant Recipients With Chronic Active Antibody Mediated Rejection
This study investigates the burden of disease among kidney transplant recipients that have developed Chronic Active Antibody Mediated Rejection (caAMR) compared with kidney transplant recipients that have not developed caAMR
- Trial name
- NCT05452317
- Testing
- Chronic active AMR group, Non-Chronic active AMR group
- Where
- 3 sites in United States
- Volunteers
- 52 people
- Sponsor
- CSL Behring
Clinical Safety of a PBM Program
The German Patient Blood Management Network
This epidemiological trial will determine whether the implementation of a PBM program is safe and effective in terms of clinical outcome compared to a pre-implementation cohort Primary endpoint is a composite outcome comprising…
- Trial name
- NCT02147795
- Where
- 2 sites in Germany
- Volunteers
- 1,000,000 people, healthy volunteers welcome
- Sponsor
- Johann Wolfgang Goethe University Hospital
Myasthenia Gravis
A Pilot Trial To Assess The Feasibility And Efficacy Of SCIG In Patients With MG Exacerbation (SCIG-MG)
This is a prospective open-label, uncontrolled, single-blind, pilot clinical trial. The primary objective is to assess the efficacy, safety, feasibility and tolerability of SCIG in patients with worsening MG.
- Trial name
- SCIG-MG (NCT02774239)
- Testing
- Human normal immunoglobulin G (IgG)
- Where
- 2 sites in Canada
- Volunteers
- 26 people
- Sponsor
- University of Alberta
Afibrinogenemia, Hypofibrinogenemia
Fibrinogen Concentrate (Human) - Efficacy and Safety Study
This is a multinational, multicenter, prospective, open-label historically controlled Phase IIIb non-inferiority clinical trial on the efficacy and safety of Fibrinogen Concentrate (Human).
- Conditions
- Afibrinogenemia, Hypofibrinogenemia, Fibrinogen Deficiency
- Trial name
- NCT00916656
- Testing
- Fibrinogen Concentrate, Human (FCH), Cryoprecipitate
- Sponsor
- CSL Behring
Hemophilia, Hemophilia A
ATHN 8: Previously Untreated Patients (PUPs) Matter Study
This is a multi-center cohort study of approximately 250 previously untreated patients (PUPs) with congenital moderate to severe hemophilia A or B in a network of up to 50 US Hemophilia Treatment Centers (HTCs).
- Conditions
- Hemophilia, Hemophilia A, Hemophilia B, Hemophilia A With Inhibitor
- Trial name
- NCT03818529
- Where
- 27 sites in United States
- Volunteers
- 237 people
- Sponsor
- American Thrombosis and Hemostasis Network
Chronic Obstructive Pulmonary Disease
Effects of Pulmonary Rehabilitation on Skeletal Muscle in COPD Patients
In a former study, the investigator observed significant differences in the response to pulmonary rehabilitation between COPD patients with the "normal" genetic variant of alpha-1 antitrypsin (PiMM) and those with a homozygous…
- Trial name
- NCT02915614
- Testing
- Pulmonary rehabilitation
- Where
- Germany
- Volunteers
- 40 people
- Sponsor
- Schön Klinik Berchtesgadener Land
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
Healthy Participants
A Study to Compare the Pharmacokinetics of CSL312 Administered by Prefilled Syringe Assembled to Autoinjector to the Pharmacokinetics Administered by Prefilled Syringe Assembled to Needle Safety Device in Healthy Subjects
This is an open-label, parallel-group, phase 1, single center study to assess the relative bioavailability of CSL312 administered subcutaneously via a prefilled syringe assembled to an autoinjector compared to a prefilled syringe…
- Trial name
- NCT05306275
- Testing
- CSL312
- Where
- United States
- Volunteers
- 132 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Healthy
Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects
Study CSL324_1003 is a single center, randomized, double-blind, placebo-controlled study designed to characterize and compare the PK properties and safety of a single subcutaneous dose of CSL324 in healthy Japanese and White…
- Trial name
- NCT04570267
- Testing
- CSL324
- Where
- Australia
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Healthy Volunteers
A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults
This will be a 2- part, phase 1, open-label, single center, single ascending dose study to investigate the pharmacokinetics (PK), pharmacodynamics (PD), safety, and tolerability of subcutaneous (SC) and intravenous (IV)…
- Trial name
- NCT04580654
- Testing
- CSL312
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- 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