Clinical trials: Solid 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.
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
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
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
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
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
Immunosuppression in Solid Organ Transplant
Belatacept in Liver Transplant Recipients
The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant
- Trial name
- NCT00555321
- Testing
- Tacrolimus, Basiliximab, Belatacept More Intensive (MI)
- Where
- 42 sites in United States, Argentina and 7 more
- Volunteers
- 260 people
- Sponsor
- Bristol-Myers Squibb
SARS-CoV-2
A Study to Evaluate Safety and Immunogenicity of mRNA-1273 Vaccine to Prevent COVID-19 in Adult Organ Transplant Recipients and in Healthy Adult Participants
This is an open-label study to evaluate the safety, reactogenicity, and immunogenicity of mRNA-1273 Severe Acute Respiratory Syndrome coronavirus (SARS-CoV-2) vaccine in adults with a kidney or liver solid organ transplant (SOT)…
- Trial name
- NCT04860297
- Testing
- mRNA-1273
- Where
- 15 sites in United States
- Volunteers
- 234 people, healthy volunteers welcome
- Sponsor
- ModernaTX, Inc.
Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant
A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV)…
- Conditions
- Respiratory Tract Viral Infections, Human Metapneumovirus (hMPV) Infection, Parainfluenza (PIV) Infection, Respiratory Syncytial Viral (RSV) Infection
- Trial name
- NCT04933968
- Testing
- ALVR106
- Where
- 21 sites in United States
- Volunteers
- 17 people
- Sponsor
- AlloVir
Cytomegalovirus (CMV)
A Study of Maribavir in Japanese People With Cytomegalovirus (CMV) Infection
The main aim of the study is to check if maribavir can treat Japanese people with Cytomegalovirus (CMV) infection, and to check side effect from the study treatment and how much maribavir participants can take without getting…
- Trial name
- NCT05137717
- Testing
- Maribavir
- Where
- 20 sites in Japan
- Volunteers
- 41 people
- Sponsor
- Takeda
CMV Infection
Study Evaluating the Efficacy and Safety of Artesunate
This study is a randomized, open-label, active comparator-controlled, dose-ranging trial of the efficacy and safety of IV artesunate in combination with IV GCV or oral VGCV and SOC treatment compared to GCV or VGCV monotherapy…
- Trial name
- NCT06853184
- Testing
- Artesunate, Ganciclovir (GCV)
- Where
- 4 sites in United States, Australia
- Volunteers
- 90 people
- Sponsor
- Amivas Inc.
Kidney Transplantation, Heart Transplantation
A Study to Determine Pharmacokinetics of Children Receiving Modigraf (Tacrolimus Granules) Following Solid Organ Transplantation
The purpose of this study is to find out how much of Modigraf is absorbed and used in the body and how fast it leaves the body (Pharmacokinetics).
- Conditions
- Kidney Transplantation, Heart Transplantation, Liver Transplantation
- Trial name
- OPTION (NCT01371331)
- Testing
- Tacrolimus granules
- Where
- 10 sites in Belgium, France and 4 more
- Volunteers
- 52 people
- Sponsor
- Astellas Pharma Europe Ltd.
Actinic Keratoses, Squamous Cell Carcinomas
Prevention of UV-induced Carcinogenic Skin Alterations in Immunosuppressed Solid Organ Transplanted Patients
The purpose of this trial is to investigate the prevention of actinic keratoses and squamous cell carcinomas by local application of MD-3511356 in comparison to standard sun protection measures in immunosuppressed solid organ…
- Trial name
- NCT01532453
- Testing
- MD-3511356, Standard Sun Protection Measures
- Where
- 10 sites in Austria, Czechia and 7 more
- Volunteers
- 244 people
- Sponsor
- Spirig Pharma Ltd.
Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD)
A Study to Evaluate Tabelecleucel in Participants With Epstein Barr Virus (EBV) Associated Diseases
The purpose of this study is to assess the efficacy and safety of tabelecleucel in participants with EBV-associated diseases.
- Conditions
- Epstein-Barr Virus (EBV)-Associated Diseases, EBV+ Lymphoproliferative Disease With Primary Immunodeficiency (EBV+ PID LPD), EBV+ Lymphoproliferative Disease With Acquired (Non-congenital) Immunodeficiency (EBV+ AID LPD), EBV+ Posttransplant Lymphoproliferative Disease in Central Nervous System (EBV+ CNS PTLD)
- Trial name
- NCT04554914
- Testing
- Tabelecleucel
- Where
- 40 sites in United States, Austria and 5 more
- Volunteers
- 190 people
- Sponsor
- Pierre Fabre Medicament
Cell-mediated Immune Response
Performance Comparison of QuantiFERON Monitor in Solid Organ Transplant Recipients
To compare the performance of the QuantiFERON Monitor assay against existing methodology.
- Trial name
- NCT02416414
- Testing
- QuantiFERON Monitor Assay, Existing methodology
- Where
- 4 sites in United States
- Volunteers
- 166 people, healthy volunteers welcome
- Sponsor
- QIAGEN Gaithersburg, Inc
Cytomegalovirus (CMV)
A Study to Evaluate the Safety and Tolerability, Pharmacokinetics, and Antiviral Activity of Maribavir for the Treatment of Cytomegalovirus (CMV) Infection in Children and Adolescents Who Have Received a Hematopoietic Stem Cell Transplant (HSCT) or a Solid Organ Transplant (SOT)
The main aim of this study is to find out the safety, tolerability and pharmacokinetics (PK) of maribavir for the treatment of CMV infection in children and teenagers after HSCT or SOT and to identify the optimal dose of…
- Trial name
- NCT05319353
- Testing
- Maribavir
- Where
- 53 sites in United States, Australia and 9 more
- Volunteers
- 80 people
- Sponsor
- Takeda
Merkel Cell Carcinoma, Basal Cell Carcinoma
Study to Investigate the Efficacy and Safety of RP1 in Adult Patients With Organ Transplants and Advanced Skin Malignancies
The purpose of this study is to assess the safety and efficacy of RP1 (administered into the tumor) in 90 patients who have received an organ transplant in the past and currently have skin cancer.
- Conditions
- Merkel Cell Carcinoma, Basal Cell Carcinoma, Locally Advanced Cutaneous Squamous Cell Carcinoma, Cancer
- Trial name
- ARTACUS (NCT04349436)
- Testing
- RP1, intra-tumoral injection, oncolytic virus
- Where
- 24 sites in United States
- Volunteers
- 69 people
- Sponsor
- Replimune, Inc.
Influenza
Assess the Risk of Solid Organ Transplant Rejection Following Vaccination With Pandemrix™ in UK
This study aims to assess the risk of solid organ transplant (SOT) rejection following vaccination with Pandemrix™ and/ or seasonal influenza vaccination.
- Trial name
- NCT01715792
- Testing
- Data collection
- Where
- United Kingdom
- Volunteers
- 587 people
- Sponsor
- GlaxoSmithKline