| Condition | Study Number | Description | Status (click on link to learn more) |
| Dermatomyositis (DM) | IgPro20_3007 | A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of IgPro20 in Adults with Dermatomyositis (DM) [RECLAIIM] | Active, Not Recruiting |
| Pediatric CIDP | IgPro10_4002 | Randomized Study of Single vs. Multiple Privigen Dose Regimens in Pediatric CIDP | Recruiting |
| Hereditary Angioedema (HAE) | CSL312_3002 | Long-term Safety and Efficacy of CSL312 (Garadacimab) in the Prophylactic Treatment of Hereditary Angioedema Attacks | Active, Not Recruiting |
| Hereditary Angioedema (HAE) | CSL312_3003 | CSL312_3003 Safety and Pharmacokinetic Study in Subjects 2 to 11 Years of Age With Hereditary Angioedema | Recruiting |
| Inflammatory Neuropathy | pHeNIx | Hizentra® in Inflammatory Neuropathies - pHeNIx Study | Recruiting |
Current Clinical Trials
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.” Clinical Trials FAQs.
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US Clinical Studies
To enroll in a US clinical study, check out our list of US Clinical Trials and click on the "Recruiting" button for the relevant trial.
Current Trials
| Condition | Study Number | Description | Status (click on link to learn more) |
| Haemophilia A | OPERA | Register of Patients With hEmophilia A tReated With Afstyla® (OPERA) | Active, Not Recruiting |
| Haemophilia B | OrPHEe | Observatory of Patients With Hemophilia B Treated by IdElvion® | Recruiting |
| Haemophilia B | CSL220_1002 | Study of AAV5-hFIX in Severe or Moderately Severe Haemophilia B | Active, Not Recruiting |
| Haemophilia B | CSL222_3001 | HOPE-B: Trial of AMT-061 in Severe or Moderately Severe Hemophilia B Patients | Active, Not Recruiting |
| Haemophilia B | CSL222_3003 | Long-term Follow-up Study of Male Adults With Hemophilia B Previously Treated With Etranacogene Dezaparvovec (CSL222) | Enrolling by Invitation |
| Haemophilia B | CSL222_3005 | Efficacy and Safety of CSL222 (Etranacogene Dezaparvovec) Gene Therapy in Adults With Hemophilia B With Pretreatment Adeno-associated Virus Serotype 5 (AAV5) Neutralizing Antibodies (Nabs) | Recruiting |
| Haemophilia B | CSL222_4001 | An Observational Cohort Study to Characterize the Effectiveness and Safety of HEMGENIX® in Patients With Hemophilia B | Recruiting |
| Traumatic Injury and Acute Major Bleeding | BE1116_3006 | Evaluation of BE1116 in Patients With Traumatic Injury and Acute Major Bleeding to Improve Survival ( TAP Study ) | Recruiting |
| Von Willebrand Disease | OPALE | Registry of Patients with Von WilLEbrand Disease Treated with Voncento® (OPALE) | Active, Not Recruiting |
| Condition | Study Number | Description | Status (click on link to learn more) |
| Alpha-1 Antitrypsin Deficiency | AmAREtTI Study | Respreeza® Self-administration and Learning Program (AmAREtTI Study- Auto-Administration de Respreeza® et Programme d'apprenTIssage) | Recruiting |
| Idiopathic Pulmonary Fibrosis | CSL312_2002 | CSL312 Safety, Pharmacokinetics, and Pharmacodynamics in Idiopathic Pulmonary Fibrosis | Active, Not Recruiting |
| Condition | Study Number | Description | Status (click on link to learn more) |
| End Stage Kidney Disease (ESKD) | CSL300_2301 | Combined Dose-Finding and CV Outcomes Study With CSL300 (Clazakizumab) in Adult Subjects With ESKD Undergoing Dialysis |
Active, Not Recruiting |
| Condition | Study Number | Description | Status (click on link to learn more) |
| 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 [IMAGINE] |
Active, Not 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 [MODULATE] |
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 | Active, Not Recruiting |
| Healthy Subjects | CSL040_1001 | First-In-Human Study To Evaluate The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Escalating Single And Multiple Doses Of CSL040 In Healthy Subjects | Recruiting |
Completed Trials
| Condition | Study Number | Description | Status (click on link to learn more) |
| 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) | Cancelled |
| Hereditary Angioedema (HAE) | CSL312_2001 | A Study to Investigate CSL312 in Subjects With Hereditary Angioedema (HAE) | Results |
| Hereditary Angioedema (HAE) | CSL312_3001 | CSL312 (Garadacimab) in the Prevention of Hereditary Angioedema Attacks | Results |
| Hereditary Angioedema (HAE) | CSL830_2001 | A Study to Evaluate the Clinical Pharmacology and Safety of C1-esterase Inhibitor Administered by the Subcutaneous Route | Results Synopsis (PDF) |
| 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 | |
| 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 | |
| Hereditary Angioedema (HAE) | CSL830_3003 | A Phase 3 Study to Evaluate Clinical Efficacy, Safety, and Pharmacokinetics of Subcutaneous Administration of Human Plasma Derived C1-esterase Inhibitor in the Prophylactic Treatment of Hereditary Angioedema in Japanese Subjects | |
| Hidradenitis Suppurativa and Palmoplantar Pustulosis | CSL324_1002 | Safety and Pharmacokinetics of Repeat Doses of CSL324 in Subjects With Hidradenitis Suppurativa and Palmoplantar Pustulosis | 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 |
|
| 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 Synopsis (PDF) |
| Primary Immune Deficiency (PID) | IgPro20_4004 | Safety and Tolerability of Higher Infusion Parameters of IgPro20 (Hizentra®) in Subjects With Primary Immunodeficiency (PID) |
Results Synopsis (PDF) |
| Primary Immune Deficiency (PID) | IgPro20_4005 | Study of Immune Deficiency Patients Treated with Subcutaneous Immunoglobulin (Hizentra®) on Weekly and Biweekly Schedules |
Results Synopsis (PDF) |
| Systemic Sclerosis | IgPro10_2001 | Efficacy and Safety Study of IgPro10 in Adults with Systemic Sclerosis | Withdrawn |
| Systemic Sclerosis | IgPro20_2001 | A Study to Investigate the Safety, Tolerability, and Pharmacokinetics of IgPro20 in Subjects with Diffuse Cutaneous Systemic Sclerosis (dcSSc). | Results |
| Healthy Subjects | CSL312_1003 | A Study to Assess the Pharmacokinetics and Safety of CSL312 in Healthy Japanese and Caucasian Adults | Completed |
| Healthy Subjects | CSL312_3004 | 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 | Completed |
| 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 | CSL324_1003 | Pharmacokinetics and Safety of Subcutaneous CSL324 in Healthy Japanese and White Subjects | Completed |
| Healthy Subjects | CSL324_1004 | Effects of CSL324 in the Lung After Segmental Challenge | Completed |
| Healthy Subjects | CSL730_1001 | Assessing the Safety and Tolerability of CSL730 in Healthy Caucasian and Japanese Adults | Cancelled |
| Healthy Subjects | CSL730_1002 | Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CSL730 in Healthy Adult Subjects | Cancelled |
| Condition | Study Number | Description | Status (click on link to learn more) |
| 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 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 |
Results Synopsis-PUP (PDF) Synopsis (PDF) |
| Hemophilia B | CSL222_2001 |
Dose Confirmation Trial of AAV5-hFIXco-Padua |
Results |
| Hemophilia B | CSL654_3001 | A Safety and Efficacy Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Patients With Hemophilia B | Results |
| Hemophilia B | CSL654_3002 |
A Safety, Efficacy and Pharmacokinetics Study of a Recombinant Fusion Protein Linking Coagulation Factor IX With Albumin (rIX-FP) in Children With Hemophilia B |
Results Synopsis (PDF) |
| 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 |
Results |
| Hemophilia B | CT-AMT-060-01 |
Trial of AAV5-hFIX in Severe or Moderately Severe Hemophilia B |
Results |
| Hemophilia A or B | CSL689_2001 |
Study of Recombinant Factor VIIa Fusion Protein (rVIIa-FP, CSL689) for On-demand Treatment of Bleeding Episodes in Patients With Hemophilia A or B With Inhibitors |
Cancelled |
| PICC-associated Thrombosis | CSL312_1002 |
A Clinical Study to Test the Efficacy and Safety of CSL312 on Catheter-associated Blood Clot Formation in Subjects With Cancer Who Receive Chemotherapy Through a PICC Line |
Withdrawn |
| Sickle Cell | CSL200_1001 |
CSL200 Gene Therapy in Adults With Severe Sickle Cell Disease |
Cancelled |
| Sickle Cell | CSL889_1001 | Safety of Single Doses of CSL889 in Adult Patients With Sickle Cell Disease | Completed |
| Von Willebrand Disease | CSLCT-BIO-12-83 | Study of Voncento® in Subjects With Von Willebrand Disease | Completed |
| Condition | Study Number | Description | Status (click on link to learn more) |
| Acute Coronary Syndrome | CSL112_3001 | Study to Investigate CSL112 in Subjects With Acute Coronary Syndrome | Completed |
| Coronary Heart Disease | CSL112_1001 | Assessing the Pharmacokinetics, Safety, and Tolerability of CSL112 in Healthy Japanese and Caucasian Adults | Completed |
| Diabetic Kidney Disease | CSL346_2001 | Vascular Endothelial Growth Factor-B (VEGF-B) Blockade With the Monoclonal Antibody CSL346 in Subjects With Diabetic Kidney Disease | Results |
| Hereditary Angioedema | 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 |
| Renal Impairment and Acute Myocardial Infarction | 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 Synopsis (PDF) |
| Acute Myocardial Infarction | CSLCT-HDL-12-77 | A Phase 2b Study of CSL112 in Subjects With Acute Myocardial Infarction. | Results Synopsis (PDF) |
| Condition | Study Number | Description | Status (click on link to learn more) |
| 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 | Results |
| Condition | Study Number | Description | Status (click on link to learn more) |
| COVID-19 | CSL312_COVID-19 | A Phase 2, Multicenter, Double Blind, Randomized, Placebo-Controlled Study to Evaluate CSL312 in Coronavirus Disease 2019 (COVID 19) | Results |
| COVID-19 | CSL324_COVID-19 | CSL324 in COVID-19 | Withdrawn |
| COVID-19 | CSL760_1001 | Pharmacokinetics, Safety, and Tolerability of CSL760, an Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin, in Healthy Adult Subjects | Cancelled |