Clinical trials: Transplantation Infection
Cytomegalovirus Infections, Heart Transplantation
A Study on the Pharmacokinetics and Safety of Valcyte (Valganciclovir) in Pediatric Heart Transplant Recipients Less Than 4 Months of Age
This open label study will assess the pharmacokinetics and the safety and tolerability of Valcyte (valganciclovir) powder for oral solution in neonatal and infant heart transplant patients < 4 months of age.
- Trial name
- NCT01165580
- Testing
- valganciclovir [Valcyte]
- Where
- 19 sites in United States, Canada and 1 more
- Volunteers
- 17 people
- Sponsor
- Hoffmann-La Roche
Infection
Observational Trial to Evaluate Hematopoietic Stem Cell Transplantation CMV Reactivation
The purpose of this study is to evaluate the ability of the T-SPOT.CMV assay to determine immune competence against CMV infection in stem cell transplantation.
- Trial name
- REACT (NCT02470208)
- Where
- 12 sites in United States, Canada and 1 more
- Volunteers
- 250 people
- Sponsor
- Oxford Immunotec
Fungal Infection, Bacterial Infection
Safety of hLF1-11 for the Treatment of Infectious Complications Among HSCT Recipients
The safety and tolerability of hLF 1-11 given in multiple doses has to be established first in HSCT recipients who are at risk of developing, but have not yet developed, infectious complications due to invasive fungal or…
- Trial name
- NCT00430469
- Testing
- human lactoferrin (hLF1-11)
- Where
- Netherlands
- Sponsor
- AM-Pharma
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
Febrile Neutropenia, Acute Leukemia
iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia
- Conditions
- Febrile Neutropenia, Acute Leukemia, Stem Cell Transplantation, Infection
- Trial name
- IDENTIFY (NCT03364257)
- Testing
- iDTECT Blood
- Where
- 5 sites in France
- Volunteers
- 97 people
- Sponsor
- Pathoquest
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
Recurrent Hepatitis C
Efficacy of Everolimus as Inhibitor of Fibrosis Progression in Liver Transplant Patients With Recurrence of Hepatitis C Viral Infection
This study will assess the efficacy of everolimus as an inhibitor of fibrosis progression in liver transplant patients who have a recurrence of hepatitis C viral infection in the transplant
- Trial name
- REVERT (NCT00582738)
- Testing
- CsA-TAC (standard Treatment), Everolimus
- Where
- Argentina
- Volunteers
- 43 people
- Sponsor
- Novartis Pharmaceuticals
Cutaneous Warts
bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients
As many as 85 % of renal transplant patients may suffer from viral warts with a high degree of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid) point to a beneficial effect without noticeable…
- Trial name
- NCT00644579
- Testing
- bLAC
- Where
- 5 sites in Denmark
- Volunteers
- 120 people
- Sponsor
- NatImmune A/S
Hepatitis C
Phase III Daclatasvir, Sofosbuvir, and Ribavirin in Cirrhotic Participants and Participants Post-liver Transplant
This trial was open to participants who had received a liver transplant or had cirrhosis due to chronic HCV. All subjects were treated with daclatasvir+sofosbuvir+ribavirin and were followed for 24 weeks post treatment.
- Trial name
- ALLY 1 (NCT02032875)
- Testing
- Daclatasvir, Sofosbuvir, Ribavirin
- Where
- 5 sites in United States
- Volunteers
- 116 people
- Sponsor
- Bristol-Myers Squibb
Cytomegalovirus (CMV)
A Study of Maribavir in Adults With Post-transplant Cytomegalovirus (CMV) Infection
The main aim of this study is to check how effective the treatment with Maribavir has been to remove the CMV viruses from the blood of an adult person with CMV infection after a transplant.
- Trial name
- NCT06615921
- Testing
- No Intervention
- Where
- 45 sites in Austria, Denmark and 8 more
- Volunteers
- 265 people
- Sponsor
- Takeda
Bone Marrow Transplant Infection
The DISCOVER Trial (Diagnosis of Infection in Stem Cell Transplant Patients OVER Time)
Demonstrate that the Karius Infectious Disease Diagnostic Sequencing Assay performed on plasma can accurately detect the microbiologic etiology in febrile allogeneic stem-cell transplant patients when compared with standard…
- Trial name
- DISCOVER (NCT02804464)
- Where
- United States
- Volunteers
- 70 people
- Sponsor
- Karius, Inc.
Leukemia, Lymphoma
Prevention of Graft-Versus-Host Disease in Patients With Advanced Leukemia or Lymphoma Who Are Eligible for Peripheral Stem Cell Transplantation
RATIONALE: Peripheral stem cell transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill tumor cells.
- Conditions
- Leukemia, Lymphoma, Graft Versus Host Disease
- Trial name
- NCT00003056
- Testing
- cyclosporine, cyclosporine and methotrexate
- Where
- 13 sites in United States, Australia
- Volunteers
- 105 people
- Sponsor
- Baxalta now part of Shire
Cytomegalovirus (CMV)
A Study of Maribavir Compared to Valganciclovir to Treat Cytomegalovirus Infections in People Who Have Received Stem Cell Transplants
This study is about treatment options for cytomegalovirus infections in people who have received stem cell transplants. The main aim of the study is to check if the cytomegalovirus infection can no longer be detected after…
- Trial name
- NCT02927067
- Testing
- Maribavir, Valganciclovir
- Where
- 129 sites in United States, Australia and 21 more
- Volunteers
- 553 people
- Sponsor
- Shire
Liver Transplantation, Infection
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of…
- Trial name
- NCT00149890
- Testing
- Basiliximab, Cyclosporine/cyclosporine microemulsion, Steroid
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- Novartis
Lung Transplant Infection, Lung Transplant; Complications
AlloSure Lung Assessment and Metagenomics Outcomes Study
ALAMO is a prospective, multi-center, perspective, registry of patients receiving LungCare™ (AlloSure®-Lung, AlloMap Lung, and HistoMap) for surveillance post-transplant.
- Conditions
- Lung Transplant Infection, Lung Transplant; Complications, Lung Transplant Failure and Rejection
- Trial name
- ALAMO (NCT05050955)
- Where
- 22 sites in United States, Canada
- Volunteers
- 550 people, healthy volunteers welcome
- Sponsor
- CareDx
Recurrent C. Difficile Infection
A Trial of CP101 for the Prevention of Recurrent CDI (PRISM4)
This is a Randomized, Double-Blind, Placebo-Controlled, Phase 3 Trial of the Efficacy, Safety, and Tolerability of a Single Oral Administration of CP101 for the Prevention of Recurrent Clostridioides difficile Infection (PRISM4).
- Trial name
- PRISM4 (NCT05153499)
- Testing
- CP101
- Where
- 68 sites in United States, Canada
- Volunteers
- 19 people
- Sponsor
- Finch Research and Development LLC.
Respiratory Syncytial Virus Infections
Effects of EDP-938 in Hematopoietic Cell Transplant Recipients Infected With Respiratory Syncytial Virus of the Upper Respiratory Tract
This was a Phase 2b, randomized, double-blind, placebo-controlled, multicenter study evaluating the efficacy and safety of EDP-938 in HCT recipients with acute RSV infection and symptoms of URTI.
- Trial name
- RSVTx (NCT04633187)
- Testing
- EDP-938
- Where
- 64 sites in United States, Argentina and 17 more
- Volunteers
- 9 people
- Sponsor
- Enanta Pharmaceuticals, Inc
Transplantation Infection
Everolimus in Combination With Cyclosporine Microemulsion in de Novo Renal Transplant Recipients
The purpose of this study was to allow the continuation of everolimus treatment in patients who have completed the core study (NCT00170885) and to collect long-term safety, tolerability, and efficacy data in a group of patients…
- Trial name
- EVEREST (NCT01276457)
- Testing
- Everolimus 0.25 and 0.75 mg tablets, Cyclosporine very low dose (150-300 ng/mL) microemulsion, Cyclosporine low dose (350-500 ng/mL) microemulsion
- Volunteers
- 223 people
- Sponsor
- Novartis Pharmaceuticals
Liver Fibrosis, Hepatic Fibrosis
A Trial of IDN-6556 in Post Orthotopic Liver Transplant for Chronic HCV
This is a double-blind, multicenter study involving patients with chronic HCV infection who had a liver transplantation; developed HCV-related liver fibrosis and/or incomplete cirrhosis; achieved a sustained virologic response…
- Conditions
- Liver Fibrosis, Hepatic Fibrosis, Liver Cirrhosis, Hepatic Cirrhosis
- Trial name
- POLT-HCV-SVR (NCT02138253)
- Testing
- IDN-6556
- Where
- 35 sites in United States
- Volunteers
- 64 people
- Sponsor
- Conatus Pharmaceuticals Inc.
Pulmonary Aspergillosis
An Open-label Safety Study of PC945 (Opelconazole) Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)
A study to evaluate the safety and tolerability of opelconazole for the prevention of fungal aspergillus infections in the lung in participants who have received a lung transplant.
- Trial name
- NCT05037851
- Testing
- Opelconazole, Standard of Care
- Where
- 19 sites in United States, Canada
- Volunteers
- 102 people
- Sponsor
- Pulmocide Ltd