Clinical trials: sponsored by 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
Coronavirus Disease 2019 (COVID-19)
Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects
CSL760 is a human hyperimmune product of the purified gamma immunoglobulin (IgG) fraction of human plasma containing polyvalent neutralizing antibodies to SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2).
- Trial name
- NCT04638634
- Testing
- CSL760
- Where
- Australia
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Rheumatoid Arthritis
Phase IIB Rheumatoid Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to Methotrexate
The purpose of this study is to determine the effective dose of BMS-945429 in subjects with inadequate response to Methotrexate in the treatment of moderate to severe Rheumatoid Arthritis.
- Trial name
- NCT01373151
- Testing
- BMS-945429, Methotrexate
- Where
- 100 sites in United States, Argentina and 17 more
- Volunteers
- 418 people
- Sponsor
- CSL Behring
Crohn's Disease
Dose Ranging Study of BMS-945429 in Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with moderate to severe Crohn's disease and who have had an insufficient response to conventional therapy or have…
- Trial name
- NCT01545050
- Testing
- BMS-945429
- Where
- 56 sites in United States, Austria and 16 more
- Volunteers
- 72 people
- Sponsor
- CSL Behring
Arthritis, Psoriatic
Psoriatic Arthritis Dose Ranging Study for BMS-945429 in Subjects Who Are Not Responding to NSAIDs or Non-biologic Disease Modifying Anti-rheumatic Drugs (DMARDs) Therapy
The purpose of this study is to characterize the safety, efficacy and dose response of BMS-945429 in subjects with active Psoriatic Arthritis and an inadequate response to Nonsteroidal anti-inflammatory drugs (NSAIDs) and…
- Trial name
- NCT01490450
- Testing
- BMS-945429
- Where
- 49 sites in United States, Argentina and 11 more
- Volunteers
- 165 people
- Sponsor
- CSL Behring
Hemophilia A, Severe Hemophilia A
An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A
This multicenter, open-label, phase 3 extension study will investigate the safety and efficacy of rVIII-SingleChain for prophylaxis and on-demand treatment of bleeding episodes in at least 200 previously treated patients (PTPs)…
- Trial name
- NCT02172950
- Testing
- rVIII-SingleChain
- Where
- 64 sites in United States, Australia and 23 more
- Volunteers
- 246 people
- Sponsor
- CSL Behring
Anemia, Sickle Cell
CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease
This is a phase 1 pilot study of CSL200 in adult subjects with severe sickle cell disease. The primary objectives of this study are to evaluate the safety of the following: collection of CD34+ hematopoietic stem / progenitor…
- Trial name
- NCT04091737
- Testing
- Autologous enriched CD34+ cell fraction that contains CD34+ cells transduced with lentiviral vector encoding human γ-globinG16D and short-hairpin RNA734
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- CSL Behring
Healthy
Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults
To assess the safety and tolerability of ascending doses of CSL730 after a single intravenous (IV) infusion in healthy Caucasian and Japanese subjects
- Trial name
- NCT03375606
- Testing
- CSL730
- Where
- 2 sites in Netherlands, United Kingdom
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- CSL Behring
Hemorrhage
An Observational Cohort Study to Investigate the Risk of Thromboembolic Events in Patients Receiving Kcentra® or Plasma to Reverse Vitamin K Antagonist (VKA) Therapy in the Setting of Acute Major Bleeding
This observational cohort study is designed to obtain product safety information from the routine clinical setting within large, diverse, community-based populations.
- Trial name
- NCT02319460
- Testing
- Kcentra®, Plasma
- Where
- United States
- Volunteers
- 2,238 people
- Sponsor
- CSL Behring
Rheumatoid Arthritis
Phase IIB Dose Ranging Study in Subjects With Moderate to Severe Rheumatoid Arthritis
The primary purpose of this study is to identify an appropriate dose of study medication.
- Trial name
- NCT02015520
- Testing
- Clazakizumab
- Where
- 55 sites in United States, Argentina and 7 more
- Volunteers
- 143 people
- Sponsor
- CSL Behring
Oral Mucositis
Safety and Efficacy of ALD518 for Reducing Oral Mucositis in Head and Neck Cancer Subjects
The purpose of this study is to evaluate the safety and efficacy of ALD518 in modifying the course of oral mucositis in subjects with head and neck cancer receiving concomitant chemotherapy and radiotherapy
- Trial name
- NCT01403064
- Testing
- ALD518, 0.9% saline
- Where
- 31 sites in United States, Australia and 4 more
- Volunteers
- 76 people
- Sponsor
- CSL Behring
Acute Myocardial Infarction
A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction.
This is a multicenter randomized, double-blind, placebo-controlled, parallel-group, dose-ranging phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of…
- Trial name
- NCT02108262
- Testing
- CSL112
- Where
- 189 sites in United States, Australia and 14 more
- Volunteers
- 1,267 people
- Sponsor
- CSL Behring
Acute GvHD
Exploratory Safety Study of ALD518 in Subjects With Steroid-refractory Acute Graft Versus Host Disease (GVHD)
The purpose of this study is to determine the safe and tolerable, biologically active, and potentially effective doses(s) of ALD518 in subjects with acute GVHD, who have failed to respond to glucocorticosteroids, for further…
- Trial name
- ALD518-010 (NCT01530256)
- Testing
- ALD518
- Where
- 5 sites in United States
- Volunteers
- 3 people
- Sponsor
- CSL Behring
Hereditary Angioedema Types I and II
A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route
The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed.
- Trial name
- NCT01576523
- Testing
- C1-esterase inhibitor - single intravenous dose, C1-esterase inhibitor - subcutaneous low dose, C1-esterase inhibitor - subcutaneous medium dose
- Where
- 8 sites in United States, Germany
- Volunteers
- 18 people
- Sponsor
- CSL Behring
Hereditary Angioedema Types I and II
A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
The aim of this study is to assess the efficacy of C1-esterase inhibitor in preventing hereditary angioedema attacks when it is administered under the skin of subjects with hereditary angioedema.
- Trial name
- NCT01912456
- Testing
- Low-volume C1-esterase inhibitor, Higher-volume C1-esterase inhibitor
- Where
- 39 sites in United States, Australia and 8 more
- Volunteers
- 90 people
- Sponsor
- CSL Behring
Chronic Inflammatory Demyelinating Polyneuropathy
Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP
Chronic inflammatory demyelinating polyneuropathy (CIDP) is a chronic demyelinating polyneuropathy of autoimmune origin with a progressive or relapsing course.
- Trial name
- HELIPAD 1 (NCT03779828)
- Testing
- HOME LINK
- Where
- 10 sites in France
- Volunteers
- 11 people
- Sponsor
- CSL Behring
Diffuse Cutaneous Systemic Sclerosis
Efficacy and Safety of IgPro10 in Adults With Systemic Sclerosis (SSc)
This randomized, multicenter, double-blind (DB), placebo controlled, phase 2 study will evaluate the efficacy and safety of IgPro10. The DB Treatment Period will be followed by a 24-week Open-label (OL) Treatment Period.
- Trial name
- NCT04138485
- Testing
- IgPro10
- Where
- 77 sites in United States, Argentina and 11 more
- Sponsor
- CSL Behring
Coronavirus Disease 2019 (COVID-19)
CSL324 in COVID-19
This is a phase 2, prospective, multicenter, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of intravenous (IV) administration of CSL324, administered in combination with…
- Trial name
- NCT04519424
- Testing
- CSL324
- Sponsor
- CSL Behring
NSCLC, Fatigue
Safety, Efficacy and Pharmacokinetics of ALD518 in Patients With Non-Small Cell Lung Cancer-related Fatigue and Cachexia
The purpose of this study is to asses the safety and efficacy of ALD518 in patients with Non-Small Cell Lung Cancer-Related Fatigue and cachexia (weight-loss).
- Conditions
- NSCLC, Fatigue, Cachexia
- Trial name
- NCT00866970
- Testing
- ALD518, Infusion of 0.9% Saline without ALD518
- Where
- 43 sites in Australia, Canada and 7 more
- Volunteers
- 124 people
- Sponsor
- CSL Behring