Clinical trials: Immunoglobulin Prophylaxis
Acute Gout
Canakinumab in the Treatment of Acute Gout Flares and Prevention of New Flares in Patients Unable to Use Non-steroidal Anti-inflammatory Drugs (NSAIDs) and/or Colchicines Including a 12 Week Extension and a 1 Year Open-label Extension Study.
The purpose of this study was to demonstrate that canakinumab given upon acute gout flares relieves the signs and symptoms and prevents recurrence of gout flares in patients with frequent flares of gout for whom non-steroidal…
- Trial name
- β-RELIEVED-II (NCT01080131)
- Testing
- Canakinumab 150 mg, Triamcinolone acetonide 40 mg
- Where
- 108 sites in United States, Canada and 3 more
- Volunteers
- 226 people
- Sponsor
- Novartis Pharmaceuticals
Venous Thromboembolism (VTE)
Treatment and Secondary Prevention of Venous Thromboembolism (VTE) in Adult Participants With Solid and Hematologic Cancers
This study is researching an experimental drug called REGN7508 (called "study drug") and will consist of 2 parts: Part 1 and Part 2.
- Trial name
- ROXI-CAT-II (NCT07493304)
- Testing
- REGN7508, Apixaban
- Where
- 13 sites in United States, Bulgaria and 3 more
- Volunteers
- 1,600 people
- Sponsor
- Regeneron Pharmaceuticals
Hepatitis B, Liver Transplantation
Efficacy and Safety of Niuliva® for the Prevention of Hepatitis B Virus Recurrence in Newly Orthotopic Liver Transplant Recipients
The aim of this clinical trial is to evaluate the efficacy, safety, and tolerability of Niuliva (Hepatitis B virus immune globulin) in the prophylaxis of hepatitis B virus (HBV) reinfection in patients submitted to liver…
- Trial name
- NCT01131065
- Testing
- Hepatitis B immune globulin
- Where
- 4 sites in Italy
- Volunteers
- 15 people
- Sponsor
- Instituto Grifols, S.A.
Transplantation, Kidney
VEL-101 to Prevent Rejection After Kidney Transplantation
This study will evaluate the safety and efficacy of VEL-101 compared with tacrolimus in patients undergoing kidney transplantation.
- Trial name
- RENGEVITY-201 (NCT07290777)
- Testing
- Tacrolimus (TAC), VEL-101
- Where
- United States
- Volunteers
- 120 people
- Sponsor
- Veloxis Pharmaceuticals
Venous Thromboembolism
A Trial to Learn How Well REGN7508 Works for Preventing Blood Clots After a Knee Replacement in Adult Participants
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement (TKR) surgery.
- Trial name
- ROXI-VTE II (NCT06454630)
- Testing
- REGN7508, Enoxaparin
- Where
- 14 sites in Bulgaria, Hungary and 3 more
- Volunteers
- 179 people
- Sponsor
- Regeneron Pharmaceuticals
Respiratory Syncytial Virus Prophylaxis
Safety Study of a Monoclonal Antibody to Respiratory Syncytial Virus (RSV) in Children Hospitalized With RSV Infection
The purpose of this study is to determine the safety of motavizumab (MEDI-524) following a single intravenous dose in children hospitalized with respiratory syncytial virus (RSV).
- Trial name
- NCT00192504
- Testing
- Motavizumab
- Volunteers
- 31 people
- Sponsor
- MedImmune LLC
Primary Sclerosing Cholangitis (PSC)
Simtuzumab (GS-6624) in the Prevention of Progression of Liver Fibrosis in Adults With Primary Sclerosing Cholangitis (PSC)
The purpose of this study is to evaluate whether simtuzumab (GS-6624) is effective at preventing the progression of liver fibrosis in adults with primary sclerosing cholangitis (PSC).
- Trial name
- NCT01672853
- Testing
- Simtuzumab
- Where
- 75 sites in United States, Belgium and 8 more
- Volunteers
- 235 people
- Sponsor
- Gilead Sciences
Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
The purpose of this study is to assess the efficacy and safety of the study drug, known as "ATG Fresenius S," which is sometimes called "EZ-2053," to prevent a lung transplant patient's body from rejecting a transplanted lung or…
- Conditions
- Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis
- Trial name
- NCT00105183
- Testing
- EZ-2053, EZ-2053 5mg/kg
- Where
- 19 sites in United States, Australia and 2 more
- Volunteers
- 223 people
- Sponsor
- Neovii Biotech
Healthy
Dose-finding Study of LFB-R593, A Monoclonal Anti-RhD Antibody, in Healthy RhD Negative Volunteers
This phase II study is designed to demonstrate the ability of LFB-R593 to effectively eliminate exogenously-administered RhD-positive red blood cells from the circulation of an RhD-negative individual, thereby preventing…
- Trial name
- NCT00952575
- Testing
- polyclonal anti-D immunoglobulin, monoclonal anti-D immunoglobulin
- Where
- Germany
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Laboratoire français de Fractionnement et de Biotechnologies
Carcinoma, Non-Small-Cell Lung
Premedication to Reduce Amivantamab Associated Infusion Related Reactions
The purpose of the study is to separately assess the potential of dexamethasone, montelukast and methotrexate administration, prior to amivantamab infusion given through a needle in the vein, to decrease the incidence and/or…
- Trial name
- NCT05663866
- Testing
- Dexamethasone, Montelukast, Methotrexate
- Where
- 36 sites in United States, France and 3 more
- Volunteers
- 68 people
- Sponsor
- Janssen Research & Development, LLC
Transplant Rejection
BIVV020 (SAR445088) in Prevention and Treatment of Antibody-mediated Rejection (AMR)
Primary Objectives: Cohort A: To evaluate the efficacy of BIVV020 in prevention of AMR Cohort B: To evaluate the efficacy of BIVV020 in treatment of active AMR Secondary Objectives: To assess the overall efficacy of BIVV020 in…
- Trial name
- NCT05156710
- Testing
- BIVV020 (SAR445088), Intravenous immunoglobulin (IVIg), Rituximab or biosimilar
- Where
- 27 sites in United States, Canada and 5 more
- Volunteers
- 48 people
- Sponsor
- Sanofi
SARS-CoV-2
Study of Monoclonal Antibody Cocktail Being Tested for the Prevention of COVID-19
This is a phase 1, randomized, double-blind, placebo-controlled, dose escalation study to evaluate the safety, pharmacokinetics, and immunogenicity of ADM03820 administered as IM injections in healthy adults for the prevention of…
- Trial name
- NCT04592549
- Testing
- ADM03820
- Where
- 2 sites in United States
- Volunteers
- 48 people, healthy volunteers welcome
- Sponsor
- Alachua Government Services, Inc.
Respiratory Syncytial Virus Infections
Study of MEDI-524 (Motavizumab) for the Prophylaxis of Serious Respiratory Syncytial Virus (RSV) Disease in High-Risk Children
The primary objective of this study was to compare the safety and efficacy of motavizumab to palivizumab when administered monthly by intramuscular (IM) injection for the reduction of the incidence of RSV hospitalization among…
- Trial name
- NCT00129766
- Testing
- motavizumab (MEDI-524), palivizumab
- Where
- 344 sites in United States, Argentina and 22 more
- Volunteers
- 6,635 people
- Sponsor
- MedImmune LLC
Virus Diseases
A Study to Evaluate Persistence of Immune Responses After Post-exposure Prophylaxis of Rabipur® (Purified Chicken-embryo Cell Rabies Vaccine) in Chinese Children
The purpose of this study is to evaluate the long-term persistence of immune responses approximately 5 years or more after simulated rabies post-exposure prophylaxis provided in 2012 according to Essen (1-1-1-1-1) or Zagreb…
- Trial name
- NCT02991872
- Testing
- Blood draw
- Where
- China
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in…
- Trial name
- NCT00507689
- Testing
- FTC/TDF, Hepatitis B Immunoglobulin (HBIg)
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Rabies, Japanese Encephalitis
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly With Japanese Encephalitis Vaccine in Toddlers
This study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses.
- Conditions
- Rabies, Japanese Encephalitis, Pre-Exposure Prophylaxis
- Trial name
- NCT00694460
- Testing
- Three 1 mL doses of Rabies vaccine and two JE vaccine, Three 0.5 mL doses of Rabies vaccine and two JE vaccine, Three 0.1mL doses of Rabies Vaccine and two JE vaccine
- Where
- Thailand
- Volunteers
- 200 people, healthy volunteers welcome
- Sponsor
- Novartis
Venous Thromboembolism (VTE)
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on adults undergoing elective, unilateral (one side) total knee replacement surgery.
- Trial name
- ROXI-APEX (NCT07015905)
- Testing
- REGN7508, Apixaban, Enoxaparin
- Where
- 47 sites in United States, Bulgaria and 6 more
- Volunteers
- 2,000 people
- Sponsor
- Regeneron Pharmaceuticals
Cancer-Associated Thrombosis (CAT)
REGN7508 in Adult Participants for Prevention of Cancer-Associated Thrombosis
This study is researching an experimental drug called REGN7508 (called "study drug"). The study is focused on the prevention of Cancer-Associated Thrombosis (CAT) in participants.
- Trial name
- ROXI-CAT-I (NCT07410117)
- Testing
- REGN7508
- Where
- 23 sites in United States, Georgia and 1 more
- Volunteers
- 1,120 people
- Sponsor
- Regeneron Pharmaceuticals
End-Stage Renal Disease, End-Stage Kidney Disease
Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007)
The purpose of this study is to evaluate the efficacy and safety of two different doses of MK-2060 (a monoclonal antibody against Factor XI) in end stage renal disease (ESRD) participants receiving hemodialysis via an…
- Conditions
- End-Stage Renal Disease, End-Stage Kidney Disease, Kidney Failure, Chronic
- Trial name
- NCT05027074
- Testing
- MK-2060
- Where
- 120 sites in United States, Argentina and 13 more
- Volunteers
- 506 people
- Sponsor
- Merck Sharp & Dohme LLC
Venous Thromboembolism
A Trial to Learn How Well REGN9933 and REGN7508 Work for Preventing Blood Clots, and How Safe They Are, in Adults Who Have a Peripherally Inserted Central Catheter (PICC)
This study is researching 2 different experimental drugs called REGN9933 and REGN7508 (called "study drugs"). The study is focused on adults undergoing a placement of a catheter in the vein, also called a 'PICC line'.
- Trial name
- ROXI-CATH (NCT06299111)
- Testing
- REGN9933, REGN7508
- Where
- 23 sites in United States, Bulgaria and 4 more
- Volunteers
- 195 people
- Sponsor
- Regeneron Pharmaceuticals