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Current Clinical Trials

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A clinical trial is a research study that is done to find out if medical treatments can improve people’s health. A medical treatment can be a drug, medical device, medical procedure, or a change in a person’s behavior such as diet or exercise. People who take part in clinical trials are volunteers. They are also called “participants."

Therapeutic Area Condition Study
Number 
Description Status
(Click on link to learn more)
Haematology and Thrombosis Hemophilia B CSL654_3003 A Safety and Efficacy Extension Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B Active, Not Recruiting
  Sickle Cell CSL200_1001 CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease Active, Not Recruiting
  Sickle Cell CSL889_1001          A Phase 1 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of CSL889 in Adult Patients With Stable Sickle Cell Disease  Recruiting 
  Hemophilia A OPERA
Register of Patients With haEmophilia A tReated With Afstyla® (OPERA)
Recruiting 
  Von Willebrand Disease OPALE Registry of Patients With Von WilLEbrand Disease Treated With Voncento® (OPALE)  Recruiting 
Cardiovascular and Metabolic Acute Coronary Syndrome CSL112_3001 Study to investigate CSL112 in Subjects With Acute Coronary Syndrome (AEGIS-II) Recruiting
  Diabetic Kidney Disease            CSL346_2001 A Phase 2a Proof of Concept Study of Vascular Endothelial Growth Factor (VEGF)-B Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease             Recruiting           
Immunology and Neurology Dermatomyositis (DM) IgPro20_3007 A study to evaluate the efficacy, safety, and pharmacokinetics of IgPro20 in adults with Dermatomyositis (DM) Recruiting
  Pediatric CIDP IgPro10_4002 Randomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP Recruiting
  Hereditary Angioedema (HAE) CSL312_2001 A study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) Active, Not Recruiting

Hereditary Angioedema (HAE)
CSL312_3001 CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks
Recruiting
  Hereditary Angioedema (HAE)
CSL312_3002 Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks Recruiting
  Hidradenitis Suppurativa and Palmoplantar Pustulosis CSL324_1002 A study of the safety and pharmacokinetics of repeat doses of CSL324 in subjects with hidradenitis suppurativa and palmoplantar pustulosis Recruiting
  Inflammatory Neuropathy pHeNIx Hizentra® in Inflammatory Neuropathies - pHeNIx Study
Not Yet Recruiting 

Systemic Sclerosis IgPro20_2001 A study to investigate the safety, tolerability, and pharmacokinetics of IgPro20 in subjects with diffuse cutaneous systemic sclerosis (dcSSc) Recruiting
  Healthy Subjects CSL324_1003 Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects Recruiting
  Healthy Subjects CSL730_1002 A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects  Recruiting
Respiratory Mild Asthma CSL311_1001 A Clinical Study to test the safety, exposure, and markers of Efficacy of CSL311 in patients with mild asthma. Recruiting
  alpha-1 antitrypsin deficiency  AmAREtTI Study  Respreeza® Self-administration and Learning Program (AmAREtTI Study- Auto-Administration de Respreeza® et Programme d'apprenTIssage)  Recruiting 
  Non-cystic Fibrosis Bronchiectasis (NCFB) CSL787_1001 Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)  Recruiting
Transplant            Antibody-mediated kidney transplant rejection  CSL300_3001  A Pivotal Phase 3 Trial to Evaluate the Safety and Efficacy of Clazakizumab for the Treatment of Chronic Active Antibody-mediated Rejection in Kidney Transplant Recipients  Recruiting 
  Acute GVHD (aGVHD) CSL964_2001 The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft‑Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant (MODULAATE) Recruiting
  Graft Versus Host Disease (GVHD) CSL964_5001 A study on the efficacy of AAT with corticosteroids compared with corticosteroids alone as first line therapy for patients with high-risk acute GVHD Recruiting

 

COMPLETED STUDIES:

COVID 19 COVID-19 CSL312_COVID-19  A Phase 2, Multicenter, Double Blind, Randomized, Placebo-Controlled Study to Evaluate CSL312 in Coronavirus Disease 2019 (COVID 19)   Completed
  COVID-19 CSL324_COVID-19 CSL324 in COVID-19 Withdrawn
Haematology and Thrombosis
Reversal of acquired coagulation factor deficiency
BE1116_4001
An Observational 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
Completed

Congenital Fibrinogen Deficiency  BI3023_4003  An Observational Cohort Study of the Safety and Efficacy of Fibrinogen Concentrate, Human (FCH) in Subjects With Congenital Fibrinogen Deficiency Completed
  Hemophilia A CSL627_3001   An Open-label Safety and Efficacy Study of Recombinant FVIII in Patients With Severe Hemophilia A  Completed
  Von Willebrand Disease CSLCT-BIO-12-83 Study of Voncento® in Subjects With Von Willebrand Disease  Completed
Cardiovascular and Metabolic Coronary Heart Disease CSL112_1001 Assessing the pharmacokinetics, safety, and tolerability of CSL112 in healthy Japanese and Caucasian adults Completed
Renal Impairment and Acute Myocardial Infarction (AMI) CSL112_2001 A Phase 2 Study to Investigate the Safety and Tolerability of Multiple Dose Administration of CSL112 in Subjects With Moderate Renal Impairment and Acute Myocardial Infarction Results
  Acute Myocardial Infarction (AMI)  CSLCT-HDL-12-77  A Phase 2b study to investigate the hepatic and renal safety and tolerability of multiple dose administration of two dose levels of CSL112 compared with placebo in subjects with acute myocardial infarction (AMI)
Results
Immunology and Neurology
Hereditary Angioedema (HAE)

CSL830_2001

A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route
Results
  Hereditary Angioedema (HAE)
CSL830_3001 A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Results
  Hereditary Angioedema (HAE)
CSL830_3002 A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema
Results 
  Hereditary Angioedema (HAE)
CSL830_3003 A Phase 3 study to evaluate clinical efficacy, safety, and pharmacokineti00cs of subcutaneous administration of human plasma derived C1-esterase inhibitor in the prophylactic treatment of hereditary angioedema in Japanese subjects 
Completed

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) IgPro20_3004 Extension Study of Maintenance Treatment with Subcutaneous Immunoglobulin (IgPro20) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Results
  Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) IgPro10_5004 Evaluating the Effectiveness of Telemonitoring System in the Management of Patients With CIDP (HELIPAD 1)  Completed
  HIV-1 CAL-USA-11 An Adaptive Phase I/II Study of the Safety of CAL-USA-11 in HIV-1 Infected Adults Previously Exposed to ART Results
  Primary Immune Deficiency (PID) IgPro20_1001 Comparison of 2 Infusion Devices With Respect to Pharmacokinetics, Safety, and Tolerability of Hizentra: An Investigational Wearable Infusor and the Crono S-PID-50 Infusion Pump  Results
  Primary Immune Deficiency (PID) IgPro20_4004 Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra®) in Subjects With Primary Immunodeficiency (PID) Results
  Primary Immune Deficiency (PID) IgPro20_4005 Study of Immune Deficiency Patients treated with Subcutaneous Immunoglobulin (IgPro20, Hizentra®) on Weekly and Biweekly Schedules Results
  Systemic Sclerosis IgPro10_2001  Efficacy and safety study of IgPro10 in adults with Systemic Sclerosis  Withdrawn
  Healthy Subjects CSL324_1001  Dose escalation, placebo-controlled phase 1 study to assess the safety and tolerability of CSL324 in healthy adults Completed
  Healthy Subjects CSL730_1001 Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults  Cancelled 
Transplant  Antibody-mediated kidney transplant rejection CSL842_3001  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  Cancelled