Clinical trials: Solid Organ Transplant
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the…
- Conditions
- Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications, Lymphoproliferative Disorders, Allogeneic Hematopoietic Cell Transplant
- Trial name
- ALLELE (NCT03394365)
- Testing
- tabelecleucel
- Where
- 71 sites in United States, Australia and 7 more
- Volunteers
- 115 people
- Sponsor
- Pierre Fabre Medicament
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.
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
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) Infection, Kidney Transplantation
A Study of CMV Vaccine (HB-101) in Kidney Transplant Patients
HB-101 is a bivalent recombinant vaccine against human CMV infection. This is a randomized, placebo-controlled, phase 2 study to assess the safety, reactogenicity, immunogenicity, and efficacy of HB-101 in CMV-Seronegative…
- Trial name
- NCT03629080
- Testing
- HB-101 vaccine
- Where
- 25 sites in United States, Denmark and 4 more
- Volunteers
- 83 people
- Sponsor
- Hookipa Biotech GmbH
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
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
Infectious Diseases, Immunocompromised Host
Metagenomic Sequencing Across the Infectious Disease Risk and Care Continuum
The AXIS Network is a prospective, multicenter observational registry designed to generate real-world evidence on the use of metagenomic sequencing in clinical practice across a broad range of patient populations, infectious…
- Conditions
- Infectious Diseases, Immunocompromised Host, Opportunistic Infections
- Trial name
- AXIS (NCT07825714)
- Volunteers
- 10,000 people
- Sponsor
- Karius, 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
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.
Graft vs Host Disease, Kidney Transplantation
Study Evaluating Sirolimus (Rapamune™) in Solid Organ Transplant Recipients
To evaluate the safety of long-term administration of sirolimus oral solution for up to 5 additional years, or until the tablet formulation is commercially available (whichever occurs first) in solid organ transplant recipients…
- Trial name
- NCT00037531
- Testing
- Sirolimus (RAPAMUNE)
- Where
- 20 sites in United States, Canada
- Volunteers
- 769 people
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
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
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.
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
VICTOR Study - A Study of Valcyte (Valganciclovir po) Compared to Ganciclovir iv in Patients With Cytomegalovirus (CMV) Disease Who Are Solid Organ Transplant Recipients
This 2 arm study will evaluate the efficacy and safety of oral Valcyte compared with intravenous ganciclovir for the treatment of CMV disease in solid organ transplant recipients.
- Trial name
- NCT00431353
- Testing
- Ganciclovir, valganciclovir [Valcyte]
- Where
- 50 sites in Australia, Austria and 19 more
- Volunteers
- 325 people
- Sponsor
- Hoffmann-La Roche
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
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
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.