Clinical trials: sponsored by CSL Behring
Hemophilia B
Joint Health Study
This is a prospective, non-randomized, controlled study to examine whether or not having a higher trough during prophylactic treatment with clotting factor offers better joint protection than the standard trough of 1% Factor IX…
- Trial name
- NCT03358836
- Where
- 5 sites in United States
- Volunteers
- 8 people
- Sponsor
- Bloodworks
Bleeding, Blood Loss, Surgical
PCC vs. FFP for Post Cardiopulmonary Bypass Coagulopathy and Bleeding
This will be the first prospective randomized controlled clinical trial directly comparing Prothrombin Complex Concentrate (PCC) Compared to Fresh Frozen Plasma (FFP) for post cardiopulmonary bypass microvascular bleeding and…
- Conditions
- Bleeding, Blood Loss, Surgical, Cardiovascular Surgical Procedures, Prothrombin Complex Concentrates
- Trial name
- NCT02557672
- Testing
- Prothrombin complex concentrate (Human), Fresh frozen plasma (FFP)
- Where
- United States
- Volunteers
- 106 people, healthy volunteers welcome
- Sponsor
- Mayo Clinic
COVID-19
Study for the Use of the IL-6 Inhibitor Clazakizumab in Patients With Life-threatening COVID-19 Infection
In this study, the investigators propose to administer clazakizumab to patients with life-threatening Coronavirus Disease 2019 (COVID-19) infection manifest by pulmonary failure and a clinical picture consistent with a cytokine…
- Trial name
- NCT04381052
- Testing
- Clazakizumab
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Columbia University
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
Hemophilia
ATHN 2: Factor Switching Study
This is a longitudinal, observational study of patients with Hemophilia A or B who are planning to switch to a newly approved coagulation factor replacement product, or who have recently switched factor products.
- Trial name
- NCT02546622
- Testing
- Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013, Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013
- Where
- 27 sites in United States
- Volunteers
- 310 people
- Sponsor
- American Thrombosis and Hemostasis Network
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
HIV Disease
Therapy to Elevate CD4 Counts in HIV-1 Disease
For more than 20 years, alpha-1-proteinase inhibitor therapy has been the standard treatment for patients who have inherited alpha-1-proteinase inhibitor deficiency.
- Trial name
- NCT01370018
- Testing
- alpha-1-Proteinase Inhibitor
- Where
- United States
- Volunteers
- 4 people, healthy volunteers welcome
- Sponsor
- Institute for Human Genetics and Biochemistry
Severe Hemophilia A
Rescue Immunotolerance Study in Induction of Immune Tolerance (ITI)-Experienced Patients (RES.I.S.T. Experienced)
The purpose of this study is to evaluate whether a concentrate containing both FVIII and von Willebrand Factor (VWF) given at a high dose will induce immune tolerance in subjects who have already experienced and failed ITI with…
- Trial name
- RESIST EXP (NCT01051076)
- Testing
- VWF/FVIII concentrates
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- City of Hope Medical Center
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
Myasthenia Gravis
Open Label Study of Subcutaneous Immunoglobulin (SCIg) in Myasthenia Gravis
The purpose of this study is to determine whether Hizentra is a safe and effective treatment for people with myasthenia gravis (MG).
- Trial name
- NCT02100969
- Testing
- HIZENTRA ®
- Where
- 5 sites in United States, Canada
- Volunteers
- 23 people
- Sponsor
- Mazen Dimachkie, MD
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
Anticoagulation, Anticoagulation Reversal
Assessment of Coagulation Factor Levels in Left Ventricular Device (LVAD )Patients Following Temporary Warfarin Reversal With Four Factor Prothrombin Complex Concentrate (4F-PCC)
Prospective assessment of vitamin K dependent coagulation factor levels after temporary warfarin reversal in participants with left ventricular assist devices (LAVD).
- Trial name
- KVAD (NCT03473132)
- Testing
- four factor prothrombin complex concentrate
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Brigham and Women's Hospital
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