Clinical trials: Post Lung Transplantation
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Double Lung Transplant (BOSTON-2)
The objective of this trial was to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in double lung transplant (DLT) recipients…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-2 (NCT03656926)
- Testing
- Liposomal Cyclosporine A, Standard of Care
- Where
- 40 sites in United States, Austria and 7 more
- Volunteers
- 169 people
- Sponsor
- Zambon SpA
Graft-versus-host Disease (GVHD)
A Study of Ruxolitinib vs Best Available Therapy (BAT) in Patients With Steroid-refractory Chronic Graft vs. Host Disease (GvHD) After Bone Marrow Transplantation (REACH3)
The purpose of this study is to assess the efficacy of ruxolitinib against best available therapy in participants with steroid-refractory chronic graft-versus-host disease (SR cGvHD).
- Trial name
- NCT03112603
- Testing
- Ruxolitinib, Extracorporeal photopheresis (ECP), Low-dose methotrexate (MTX)
- Where
- 191 sites in United States, Australia and 29 more
- Volunteers
- 330 people
- Sponsor
- Incyte Corporation
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc
Chronic Graft-Versus-Host Disease (cGVHD)
A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD)
The purpose of this study is to determine if vimseltinib is safe, tolerable and works effectively to treat adults with active moderate to severe cGVHD.
- Trial name
- NCT06619561
- Testing
- Vimseltinib
- Where
- 26 sites in United States
- Volunteers
- 48 people
- Sponsor
- Deciphera Pharmaceuticals, LLC
Graft-versus-host Disease (GVHD)
A Study of Tacrolimus/Methotrexate/Ruxolitinib Versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation (BMT CTN 2203)
The purpose of this study is to assess Tacrolimus/Methotrexate/Ruxolitinib versus Post-Transplant Cyclophosphamide/Tacrolimus/Mycophenolate Mofetil in Non-Myeloablative/Reduced Intensity Conditioning Allogeneic Peripheral Blood…
- Trial name
- NCT06615050
- Testing
- Tacrolimus (Tac), Methotrexate (MTX), Ruxolitinib (Rux)
- Where
- 30 sites in United States
- Volunteers
- 572 people
- Sponsor
- Incyte Corporation
COVID-19
Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine
This is an open-label, single-arm clinical trial designed to evaluate the immunogenicity and safety of a booster dose of an adjuvanted recombinant SARS-CoV-2 spike protein subunit vaccine (SpikoGen) produced by CinnaGen Co.
- Trial name
- NCT05285384
- Testing
- SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant
- Where
- Iran
- Volunteers
- 43 people
- Sponsor
- Cinnagen
Bronchiolitis Obliterans Syndrome
A Retrospective Chart Review Study of Patients With CLAD-BOS Post Lung Transplantation
The Primary Objective of this study was to evaluate the FEV1 trajectory of patients diagnosed with CLAD-BOS. The Secondary Objectives of this study were: To describe demographics of patients diagnosed with CLAD-BOS To describe…
- Trial name
- NCT06503770
- Where
- 6 sites in United States, Belgium and 1 more
- Volunteers
- 284 people
- Sponsor
- Zambon SpA
Bronchiolitis Obliterans, Obliterative Bronchiolitis
Extension Trial on Efficacy / Safety of L-CsA + SoC in Treating BOS in Post Single or Double Lung Transplant (BOSTON-3)
The objective of the trial is to assess the long-term safety and efficacy of L-CsA plus Standard of Care (SoC) in the treatment of BOS in single (SLT) and double lung transplant (DLT) recipients.
- Conditions
- Bronchiolitis Obliterans, Obliterative Bronchiolitis, Bronchiolitis Obliterans Syndrome
- Trial name
- BOSTON-3 (NCT04039347)
- Testing
- Liposomal Cyclosporine A 5 mg, Liposomal Cyclosporine A 10 mg
- Where
- 37 sites in United States, Austria and 7 more
- Volunteers
- 164 people
- Sponsor
- Zambon SpA
Ischemia-Reperfusion Injury, Lung Transplantation
Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
The objective of this clinical study was to evaluate whether CXCL8 (CXC ligand 8 [formerly interleukin (IL)-8]) inhibition with repertaxin leads to reduced severity of primary graft dysfunction, as the result of improved…
- Trial name
- NCT00224406
- Testing
- Repertaxin
- Where
- 6 sites in United States, Canada
- Volunteers
- 114 people
- Sponsor
- Dompé Farmaceutici S.p.A
Lung Transplant Rejection
LAMBDA 002 (Lung Registry) Study
The LAMBDA 002 registry study is an observational, longitudinal, multi-center study observing patients undergoing lung transplant.
- Trial name
- NCT05170425
- Testing
- Prospera
- Where
- 11 sites in United States
- Volunteers
- 154 people
- Sponsor
- Natera, Inc.
Graft vs Host Disease
Activity, Safety and Pharmacokinetics in Pediatric Subjects With Moderate and Severe Chronic Graft vs. Host Disease After Allogeneic Stem Cell Transplant
This open-label, single-arm, Phase II multi-center study enrolled 46 participants and investigated the activity, pharmacokinetics and safety of ruxolitinib added to the subject's immunosuppressive regimen among infants, children…
- Trial name
- REACH 5 (NCT03774082)
- Testing
- INC424
- Where
- 21 sites in Brazil, Canada and 12 more
- Volunteers
- 46 people
- Sponsor
- Novartis Pharmaceuticals
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
PGD Primary Graft Dysfunction
Study in Intensive Care Patients Regarding the Effect of Inhaled AP-301 After Primary Graft Dysfunction After Lung Transplantation
The purpose of this study is to investigate the effect of orally inhaled AP-301 on primary graft dysfunction after lung transplantation.
- Trial name
- NCT02095626
- Testing
- AP-301, saline solution
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Apeptico Forschung und Entwicklung GmbH
Hepatitis C, Hepatocellular Carcinoma
Efficacy of Sofosbuvir With Ribavirin Administered Pre-Transplant in Preventing Hepatitis C Virus (HCV) Recurrence Post-Transplant
The primary objective is to determine if the administration of a combination of sofosbuvir (SOF; GS-7977; PSI-7977) and ribavirin (RBV) to HCV-infected adults with hepatocellular carcinoma (HCC) meeting the MILAN criteria prior…
- Trial name
- NCT01559844
- Testing
- Sofosbuvir, Ribavirin
- Where
- 15 sites in United States, New Zealand and 1 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Bronchiolitis Obliterans Syndrome (BOS), GVHD, Chronic
A Safety Study of Liposomal Cyclosporine A to Treat Bronchiolitis After Hematopoietic Transplant (BOSTON-4)
Primary Objective: The primary objective of this study is to assess the tolerability and safety of two dose levels of aerosolized L-CsA vs placebo in addition to SoC therapy for BOS in adult allo-HSCT recipients.
- Conditions
- Bronchiolitis Obliterans Syndrome (BOS), GVHD, Chronic, Stem Cell Transplant Complications
- Trial name
- BOSTON-4 (NCT04107675)
- Testing
- Liposomal Cyclosporine A
- Where
- 17 sites in France, Germany and 1 more
- Volunteers
- 6 people
- Sponsor
- Zambon SpA
Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant
Efficacy + Safety of Liposome Cyclosporine A to Treat Bronchiolitis Obliterans Post Single Lung Transplant (BOSTON-1)
The objective of this trial is to assess the efficacy and safety of aerosolized liposomal cyclosporine A (L-CsA) as add-on therapy to standard of care (SoC) as compared to SoC alone in single lung transplant recipients with…
- Conditions
- Bronchiolitis Obliterans, Chronic Rejection of Lung Transplant, Lung Transplant Rejection, Lung Transplant; Complications
- Trial name
- BOSTON-1 (NCT03657342)
- Testing
- Liposomal Cyclosporine A, standard of care
- Where
- 39 sites in United States, Belgium and 5 more
- Volunteers
- 62 people
- Sponsor
- Zambon SpA
Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease
Early Access Program Using Alpha 1 Antitrypsin Infusion for Patients With Steroid Refractory Acute GvHD After Hematopoietic Stem Cell Transplantation (HSCT)
An Early Access Program for patients with steroid refractory acute GvHD after hematopoietic stem cell transplantation. This Program is available for female and male who are recipients of allogenic HSCT and who have been newly…
- Conditions
- Acute-graft-versus-host Disease, Steroid Refractory Acute Graft Versus Host Disease, Graft-versus-host-disease, Graft Vs Host Disease
- Trial name
- NCT03172455
- Testing
- Glassia
- Sponsor
- Impatients N.V. trading as myTomorrows
Kidney Transplantation, Transplantation
Pre-transplant Assessment of Tacrolimus Blood Level Concentration, as a Predictor of Tacrolimus Dose Requirements After Kidney Transplantation
The purpose of this study is to evaluate two groups of kidney transplant recipients, to determine the proportion of patients that achieve therapeutic blood concentrations of tacrolimus by Day 3 after transplantation.
- Trial name
- NCT00297310
- Testing
- tacrolimus
- Volunteers
- 89 people
- Sponsor
- Janssen-Cilag Pty Ltd