Clinical trials: Immunoglobulin Prophylaxis
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
Antibody Mediated Rejection
Safety & Efficacy of Eculizumab to Prevent AMR in Living Donor Kidney Transplant Recipients Requiring Desensitization
The purpose of this trial was to determine the safety and efficacy of eculizumab in the prevention of antibody-mediated rejection (AMR) in sensitized recipients of a living donor kidney transplant requiring desensitization…
- Trial name
- NCT01399593
- Testing
- Eculizumab
- Where
- 41 sites in United States, Australia and 8 more
- Volunteers
- 102 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Lymphoma, Malignant Solid Neoplasm
Xisomab 3G3 for the Prevention of Catheter-Associated Thrombosis in Patients With Cancer Receiving Chemotherapy
This phase II trial studies how well xisomab 3G3 works in preventing catheter-associated blood clots (thrombosis) in patients with cancer receiving chemotherapy.
- Conditions
- Lymphoma, Malignant Solid Neoplasm, Plasma Cell Myeloma
- Trial name
- NCT04465760
- Testing
- Xisomab 3G3
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- OHSU Knight Cancer Institute
Rabies
Comparison of SYN023 to Human Rabies Immune Globulin in Post Exposure Prophylaxis of Rabies
This is a Phase 2b, double blinded, randomized study of SYN023 compared to HyperRab® (a licensed Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis (PEP).
- Trial name
- ARPEP (NCT03961555)
- Testing
- SYN023, HRIG (HyperRab), Rabies vaccine
- Where
- 14 sites in United States, Philippines
- Volunteers
- 448 people
- Sponsor
- Synermore Biologics Co., Ltd.
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 Infections
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.
The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering…
- Trial name
- MEDI8897 Ph2b (NCT02878330)
- Testing
- MEDI8897
- Where
- 161 sites in United States, Argentina and 21 more
- Volunteers
- 1,453 people, healthy volunteers welcome
- Sponsor
- MedImmune LLC
Tetanus
Study to Compare the Efficacy and Safety of Passive Immunization With TNM002 Injection and Human Tetanus Immunoglobulin as Prophylaxis Against Tetanus
TNM002 Injection is a recombinant fully human native monoclonal antibody (mAb) against tetanus toxin and is currently under development for indication of prophylaxis against tetanus.
- Trial name
- NCT05664750
- Testing
- TNM002, Human tetanus immunoglobulin (HTIG)
- Where
- 28 sites in China
- Volunteers
- 675 people
- Sponsor
- Zhuhai Trinomab Pharmaceutical Co., Ltd.
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
Hepatitis B, Liver Transplantation
Adefovir Plus Vaccination in Transplant Patients Without Hepatitis B That Receive a Core Antibody Positive Liver
The primary purpose of this study is to evaluate the efficacy of adefovir (ADV) in preventing de novo Hepatitis B in patients who receive Hepatitis B core antibody (HBcAb) positive grafts but who are not Hepatitis B Surface…
- Trial name
- NCT01146808
- Testing
- Adefovir dipivoxil and hepatitis B vaccination
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Columbia University
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
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
Meningococcal Disease
Evaluation of Meningococcal ACWY Immune Response in Children Aged 40 and 60 Months
The purpose of this study is to evaluate how well the immuno response against meningococcal serogroups A, C, W and Y lasts in children who were vaccinated with MenACWY as infants.
- Trial name
- NCT00601731
- Testing
- MenACWY-CRM197, Blood test
- Where
- 3 sites in Canada, United Kingdom
- Volunteers
- 382 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
Meningococcal Disease
Extension Study Evaluating Antibody Persistence and Safety, Tolerability and Immunogenicity of Booster Doses of Novartis rMenB±OMV NZ Vaccine in Healthy UK Children Who Previously Received One or Four Doses of the Same Vaccine
The proposed study V72P6E1 is an Extension Study of V72P6 (NCT00381615). The objectives of this extension study will be to explore antibody persistence at approximately 40 months of age and to evaluate the safety, tolerability…
- Trial name
- NCT01027351
- Testing
- Meningococcal (group B) multicomponent recombinant adsorbed vaccine., Meningococcal (group B) multicomponent recombinant adsorbed vaccine, without Outer Membrane Vesicles (OMV)
- Where
- United Kingdom
- Volunteers
- 163 people, healthy volunteers welcome
- Sponsor
- Novartis Vaccines
HIV, Sexually Transmitted Infections (STI)
Monoclonal Antibody-based Multipurpose Microbicides
The purpose of this project is to explore women's thoughts, opinions, and ideas about vaginal products. Women who enroll in the project will complete a brief demographics and sexual behavior questionnaire.
- Trial name
- Project WIND (NCT01859195)
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- The Miriam Hospital
Malaria
Trial to Evaluate L9LS in Healthy Adults
Background: Malaria is a parasitic disease carried by mosquitoes in tropical areas. There is no vaccine to prevent malaria infection. If not treated right away, it can become serious or deadly.
- Trial name
- VRC 614 (NCT05019729)
- Testing
- VRC-MALMAB0114-00-AB, Plasmodium falciparum (P. falciparum) sporozoite challenge
- Where
- United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Coronary Artery Bypass Graft Surgery, Presence of Heparin/Platelet Factor 4 Antibody
Significance of Antibodies to Heparin/Platelet Factor 4 Complex in Vein Graft Patency and Potential Role of Argatroban for Prevention of Vein Graft Occlusion
Heparin/Platelet Factor 4 (PF4) antibody testing will be performed in subjects who have just undergone coronary artery bypass grafting (CABG) surgery.
- Trial name
- NCT01246011
- Testing
- Argatroban and warfarin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Massachusetts General Hospital
Motavizumab Administration for a Second Season for RSV Prophylaxis
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Motavizumab (MEDI-524) After Dosing for a Second Season in Children
The primary objective of this study was to determine the effect on immune reactivity to motavizumab (MEDI-524) of monthly intramuscular (IM) doses of motavizumab (MEDI-524) administered for a second season in children.
- Trial name
- NCT00113490
- Testing
- motavizumab (MEDI-524), palivizumab 15 mg/kg
- Where
- 6 sites in Brazil, Chile
- Volunteers
- 136 people
- Sponsor
- MedImmune LLC
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
Rabies, Communicable Disease
A Phase III Clinical Study to Evaluate SYN023's Efficacy and Safety
This is a Phase 3, blinded, randomized study of SYN023 compared to a China licensed Human Rabies Immunoglobulin (a Rabies immune globulin from human sources, HRIG) for the prevention of rabies as part of post-exposure prophylaxis…
- Conditions
- Rabies, Communicable Disease, Virus Diseases, Rhabdoviridae Infections
- Trial name
- NCT04644484
- Testing
- SYN023, Human Rabies Immune Globulin (HRIG), Rabies Vaccine
- Where
- China
- Volunteers
- 1,000 people
- Sponsor
- Synermore Biologics (Suzhou) Co., Ltd.
Healthy Participants
Influenza Virus Vaccine Plus Vitamin A and D Supplements for Prevention of Respiratory Virus Infections in Children
Children are particularly vulnerable to respiratory virus infections, especially influenza. Vitamin A \& D deficiencies are associated with vulnerability to infectious diseases of the respiratory tract.
- Trial name
- NCT02649192
- Testing
- Influenza virus vaccine, Vitamins A and D
- Where
- United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- St. Jude Children's Research Hospital