Clinical trials: sponsored by CSL Behring
Healthy Volunteers
Pharmacokinetics and Pharmacodynamics of Two Prolonged-release Formulations of Vamifeport in Healthy Adults
This is a phase 1, single-center, randomized, open-label study to characterize the pharmacokinetics (PK), pharmacodynamics (PD), and safety of vamifeport after multiple oral administrations of one immediate-release (IR)…
- Trial name
- NCT06726863
- Testing
- Vamifeport IRF, Vamifeport PR1, Vamifeport PR2
- Where
- United Kingdom
- Volunteers
- 22 people, healthy volunteers welcome
- Sponsor
- CSL Behring
CIDP
Validation of Cutaneous Nerve Demyelination in Diagnosis and Treatment of CIDP
The goal of this observational study is to learn about chronic inflammatory demyelinating polyneuropathy. The main question the investigators would like to answer is 1) can skin biopsy identify demyelination better than nerve…
- Trial name
- NCT05614128
- Testing
- IVIg
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- Vanderbilt University Medical Center
Alpha-1 Antitrypsin Deficiency
Respreeza® Self-administration and Learning Program (AmAREtTI Study)
According to the Respreeza® Summary of Product Characteristics, the initial infusions must be administered under the supervision of a health professional experienced in the treatment of alpha-1 antitrypsin deficiency, although…
- Trial name
- AmAREtTI (NCT04262284)
- Where
- 11 sites in France
- Volunteers
- 15 people
- Sponsor
- CSL Behring
Heart Disease End Stage, Heart Failure，Congestive
Administration of Prothrombin Complex Concentrate vs. Standard Transfusion During/After Heart Transplantation
This study is comparing the use of Kcentra vs. standard transfusion in patients undergoing heart transplantation surgery. Half of the patients will receive Kcentra, while the other half will receive fresh frozen plasma.
- Trial name
- OPSTAHT (NCT03341156)
- Testing
- Kcentra, Frozen Plasma Product, Human
- Where
- 3 sites in United States
- Volunteers
- 14 people
- Sponsor
- University of Maryland, Baltimore
Anemia, Coagulopathy
Patient Blood Management Implementation in CEE Study
The goal of the study is data collection on available fixed and personal assets required for Patient Blood Management (elements of the 3 pillars of PBM) in Central Eastern Europe countries hospitals, status before and after PBM…
- Trial name
- CEEPBM (NCT06878105)
- Testing
- Data collection on interventions performs as per medical routine
- Where
- Hungary
- Volunteers
- 2,000 people
- Sponsor
- Semmelweis University
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
Haemophilia A
Register of Patients With haEmophilia A tReated With Afstyla®
Record real life data of patients with Hemophilia A and treated with Afstyla® to assess the effectiveness and the safety of the treatment used as prophylaxis, prevention of bleeding (e.g.
- Trial name
- OPERA (NCT04675541)
- Testing
- Afstyla®
- Where
- 17 sites in France
- Volunteers
- 62 people
- Sponsor
- CSL Behring
Haemophilia B
Observatory of Patients With Haemophilia B Treated by IdElvion®
OrPHEe is a non-interventional, prospective and national study which aim is to record real life data in haemophilia B French patients treated with Idelvion® to confirm the efficacy and safety of this product established in…
- Trial name
- OrPHEe (NCT05086575)
- Where
- 28 sites in France
- Volunteers
- 222 people
- Sponsor
- CSL Behring
Chronic Inflammatory Demyelinating Polyneuropathy
Hizentra® in Inflammatory Neuropathies - pHeNIx Study
The pHeNIx study, a national multicentre prospective non-interventional study, should help to describe the conditions of use for Hizentra® and the methods for switching from the IV to SC route in everyday practice, together with…
- Trial name
- pHeNIx (NCT04672733)
- Testing
- Hizentra
- Where
- 27 sites in France
- Volunteers
- 100 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
Chronic Inflammatory Demyelinating Polyneuropathy
Subcutaneous Immunoglobulin for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
The investigators are using self administered subcutaneous immunoglobulin (SCIG) in patients with CIDP who require Intravenous immunoglobulin (IVIG). Safety, efficacy, and patient satisfaction will be examined.
- Trial name
- SCIG (NCT02465359)
- Testing
- Immune Globulin Subcutaneous (Human)
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- University of South Florida
Acute Kidney Injury, Surgery-Complications
Precision Medicine in Cardiovascular Surgery Associated Acute Kidney Injury
The goal of this prospective observational study is to define a risk profile for cardiovascular surgery associated acute kidney injury (AKI), using clinical patient characteristics, operation parameters as well as blood and urine…
- Conditions
- Acute Kidney Injury, Surgery-Complications, Frailty
- Trial name
- PEAK (NCT06471621)
- Where
- Switzerland
- Volunteers
- 100 people
- Sponsor
- Insel Gruppe AG, University Hospital Bern
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
Von Willebrand Disease
Registry of Patients With Von WilLEbrand Disease Treated With Voncento®
Description of the long-term evolution of patients with von Willebrand disease and treated with Voncento® and of the hemostatic efficacy in the prevention and the treatment of non-surgical bleeding episodes and prevention of…
- Trial name
- OPALE (NCT04657887)
- Testing
- Voncento®
- Where
- 17 sites in France
- Volunteers
- 135 people
- Sponsor
- CSL Behring
Immune Deficiency
Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
This study is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency.
- Trial name
- NCT03968211
- Testing
- Salmonella typhi polysaccharide vaccine
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- University of Virginia
Encephalitis
Investigating the Role of Early Intravenous Immunoglobulin Treatment for Children With Encephalitis
This is a phase III multi-centre randomised, double blind, placebo controlled trial to assess the role of intravenous immunoglobulin in the treatment of children with encephalitis.
- Trial name
- IgNiTE (NCT02308982)
- Testing
- Immunoglobulins, Intravenous (Privigen)
- Where
- 25 sites in United Kingdom
- Volunteers
- 18 people
- Sponsor
- University of Oxford
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
Asthma
A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers
This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma.
- Trial name
- NCT04082754
- Testing
- Human beta common receptor antagonist monoclonal antibody
- Where
- 3 sites in Germany, United Kingdom
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- 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