Clinical trials: Organ Transplantation
CMV Viremia, CMV Disease
Expanded Access Protocol of ATA230 (Third-Party Donor-Derived CMV-CTLs) for the Treatment of CMV Viremia or Disease
This is an expanded access protocol designed to provide access of ATA230 to subjects with cytomegalovirus (CMV) viremia or disease, who are intolerant to, or failed, standard antiviral therapy and have no comparable treatment…
- Trial name
- NCT03010332
- Testing
- Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)
- Sponsor
- Atara Biotherapeutics
Actinic Keratoses, Skin Neoplasms
ALA-PDT Versus Vehicle PDT for Treatment of AK and Reduction of New NMSC in Solid Organ Transplant Recipients
The purpose of this study is to determine and compare the safety and efficacy of broad area photodynamic therapy with aminolevulinic acid (ALA-PDT) versus vehicle PDT (VEH-PDT) in the treatment of actinic keratoses (AK) and…
- Trial name
- NCT00865878
- Testing
- Aminolevulinic Acid, Vehicle
- Where
- 7 sites in United States
- Volunteers
- 6 people
- Sponsor
- DUSA Pharmaceuticals, Inc.
Liver Transplant
OCS Liver PROTECT Continued Access Protocol
Continued Access Protocol to evaluate the effectiveness of the OCS Liver System to preserve and assess donor livers.
- Trial name
- NCT04186221
- Testing
- OCS Liver System
- Where
- 17 sites in United States
- Volunteers
- 74 people
- Sponsor
- TransMedics
Liver Transplantation, Liver Preservation for Transplant
OCS Liver PROTECT Trial: Preserving and Assessing Donor Livers for Transplantation
A prospective, phased-pivotal, international randomized trial to evaluate the effectiveness of the OCS™ Liver to preserve and assess donor livers intended for transplantation.
- Trial name
- PROTECT (NCT02522871)
- Testing
- OCS™ Liver System, Control
- Where
- 20 sites in United States
- Volunteers
- 300 people
- Sponsor
- TransMedics
Solid Organ Transplant Rejection, Organ Rejection Transplants
Expanded Access for Use of ExoFlo in Abdominal Solid Organ Transplant Patients
This Expanded Access Protocol will provide access to the IMP ExoFlo for patients who have severe or life-threatening abdominal solid organ transplant rejection or who are evaluated and determined to be at high risk of progression…
- Conditions
- Solid Organ Transplant Rejection, Organ Rejection Transplants, Organ Rejection
- Trial name
- NCT05215288
- Testing
- ExoFlo
- Where
- 2 sites in United States
- Sponsor
- Direct Biologics, LLC
Kidney Transplantation
A Safety and Efficacy Study of FCR001 Cell Therapy in Previously Transplanted Living Donor Kidney Recipients
An open-label study to assess the safety, tolerability, and efficacy of FCR001 cell therapy in adult recipients 3-12 months after kidney transplantation from a living donor.
- Trial name
- FREEDOM-2 (NCT01649388)
- Testing
- FCR001
- Where
- 3 sites in United States
- Sponsor
- Talaris Therapeutics Inc.
End Stage Liver DIsease, Liver Failure
Bridge to HOPE: Hypothermic Oxygenated Perfusion Versus Cold Storage Prior to Liver Transplantation
This is a prospective, multi-center, controlled, randomized, pivotal study to evaluate the safety and effectiveness of the VitaSmart™ Liver Machine Perfusion System by comparing clinical outcomes in patients undergoing liver…
- Trial name
- NCT05045794
- Testing
- VitaSmart™Liver Machine Perfusion System, Static cold storage
- Where
- 15 sites in United States
- Volunteers
- 228 people
- Sponsor
- Bridge to Life Ltd.
Cytomegalovirus (CMV)
A Study on Cytomegalovirus (CMV) Infection Outcomes Among Solid Organ Transplant (SOT) Participants in Europe and Canada
The main aim of the study is to assess the clinical outcomes of current CMV management across different regions of the world (Europe [EU] and Canada [CAN]). Data will be collected retrospectively from medical charts.
- Trial name
- NCT05576805
- Where
- 15 sites in Austria, Belgium and 7 more
- Volunteers
- 159 people
- Sponsor
- Takeda
Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders
Expanded Access Protocol for Tabelecleucel for Patients With Epstein-Barr Virus-Associated Viremia or Malignancies
The primary objective of this protocol is to provide expanded access to tabelecleucel to participants with Epstein-Barr virus-associated diseases and malignancies for whom there are no other appropriate therapeutic options, and…
- Conditions
- Epstein-Barr Virus (EBV) Infections, Lymphoproliferative Disorders, EBV+ Associated Lymphoma, EBV+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD)
- Trial name
- NCT02822495
- Testing
- tabelecleucel
- Sponsor
- Atara Biotherapeutics
HCMV Reactivation or HCMV End-Organ Disease
Safety and Efficacy Study of a New Antiviral Drug to Prevent Cytomegalovirus Reactivation in Bone Marrow Transplanted Patients
The aim of the study is to find out whether AIC246 is safe and efficacious in lowering the chances of the cytomegalovirus becoming active again and causing illness after an HBPC transplant (allogeneic stem cell transplant).
- Trial name
- NCT01063829
- Testing
- 60 mg AIC246, 120 mg AIC246, 240 mg AIC246
- Where
- 24 sites in United States, Germany
- Volunteers
- 133 people
- Sponsor
- AiCuris Anti-infective Cures AG
Kidney Transplantation
A Study of the Impact of an Early Biopsy in Patients Treated With CellCept (Mycophenolate Mofetil) After Kidney Transplantation
This 2 arm study will evaluate the impact on fibrosis at week 52 of an early biopsy, in patients who have received a kidney transplant from an expanded criteria donor.
- Trial name
- NCT00817687
- Testing
- mycophenolate mofetil [CellCept]
- Where
- 17 sites in France
- Volunteers
- 66 people
- Sponsor
- Hoffmann-La Roche
Organ Transplant Rejection, Psoriasis
Safety and Pharmacokinetics of Sustained-release Depot Tacrolimus: A First-in-human Study
This first-in-human study is designed to assess the safety and pharmacokinetic (PK) profile of sustained-release (SR) depot tacrolimus, which will be administered as a single dose of 0.1 mg/kg by subcutaneous (SC) injection in…
- Trial name
- NCT03626714
- Testing
- Sustained Release Injectable Tacrolimus
- Where
- United States
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Auritec Pharmaceuticals
Heart Transplantation, Kidney Transplantation
A Study to Compare How the Body Absorbs and Processes Two Different Formulations of the Anti-rejection Medication Tacrolimus (Advagraf® or Prograf®) in Children Receiving an Organ Transplant, and How Safe and Effective They Are Over a Longer Period of Time
The purpose of this study is to compare how the body absorbs and processes two different formulations of the anti-rejection medication tacrolimus (Advagraf® or Prograf®) in children receiving an organ transplant, and how safe and…
- Conditions
- Heart Transplantation, Kidney Transplantation, Liver Transplantation
- Trial name
- NCT01614665
- Testing
- Tacrolimus, Tacrolimus prolonged release
- Where
- 10 sites in Czechia, France and 3 more
- Volunteers
- 44 people
- Sponsor
- Astellas Pharma Europe Ltd.
Renal Transplantation
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney transplant.
- Trial name
- NCT00239798
- Testing
- FTY720
- Volunteers
- 255 people
- Sponsor
- Novartis Pharmaceuticals
Renal Transplantation
Efficacy and Safety of FTY720 in de Novo Adult Renal Transplant Recipients
This study will evaluate the safety and efficacy of FTY720 combined with cyclosporine and corticosteroids in patients receiving a kidney organ transplant
- Trial name
- NCT00239785
- Testing
- FTY720
- Volunteers
- 684 people
- Sponsor
- Novartis Pharmaceuticals
Infection in Solid Organ Transplant Recipients
T-SPOT.CMV and T-SPOT.PRT Diagnostic Assays
The T-SPOT assay quantifies the number of peripheral blood interferon-γ producing effector T cells [spot forming cells/million peripheral blood mononuclear cells - PBMC)].
- Trial name
- PROTECT (NCT02382211)
- Where
- 39 sites in United States, Canada and 1 more
- Volunteers
- 600 people
- Sponsor
- Oxford Immunotec
Advanced Heart Failure, Heart Transplantation
TORCH-LATAM-002: Regional Pathway for Adult Heart Transplant Evaluation and Candidacy
TORCH-LATAM-002 is a pragmatic stepped-wedge cluster randomized trial evaluating an integrated regional pathway for adults with advanced heart failure who require specialized heart transplant evaluation and a documented candidacy…
- Conditions
- Advanced Heart Failure, Heart Transplantation, Acquired Heart Disease
- Trial name
- TORCH-002 (NCT07836803)
- Testing
- TORCH Adult Heart Transplant Evaluation and Candidacy Pathway
- Volunteers
- 360 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Cytomegalovirus Infections
A Study of Valcyte (Valganciclovir) Syrup Formulation in Pediatric Solid Organ Transplant Recipients
This study will assess the safety and pharmacokinetics of Valcyte syrup in pediatric solid organ transplant recipients. The anticipated time on study treatment is 3-12 months and the target sample size is less than 100…
- Trial name
- NCT00090766
- Testing
- valganciclovir [Valcyte]
- Where
- 17 sites in United States, Australia and 5 more
- Volunteers
- 63 people
- Sponsor
- Hoffmann-La Roche
Immunosuppressant(Organ Transplantation, RA)
Tacrobell tab_Phase1_PK
A randomized, open-label, two-way crossover study to assess the tolerability and pharmacokinetics of Tacrobell® Tab. and Prograf® Cap. after a single oral dose in healthy male volunteers.
- Trial name
- NCT02336854
- Testing
- Tacrobell tab. 2mg, Prograf cap. 2mg
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Chong Kun Dang Pharmaceutical
CMV Retinitis
Evaluation of Safety and Efficacy of Autologous LB-DTK-CMV in Patients With Antiviral-Resistant and Refractory Cytomegalovirus Retinitis.
The goal of this exploratory clinical study is to evaluate the safety and efficacy of Cytomegalovirus-Specific T cells (LB-DTK-CMV) to treat patients diagnosed with antiviral-resistant and refractory cytomegalovirus retinitis.
- Trial name
- NCT07679412
- Testing
- LB-DTK-CMV
- Where
- South Korea
- Volunteers
- 5 people
- Sponsor
- LucasBio