Clinical trials: 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
Cytomegalovirus Infections
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis.
- Trial name
- NCT00377741
- Testing
- valganciclovir [Valcyte]
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Hoffmann-La Roche
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
Lung Transplantation
OCS Lung System EXPAND II Trial
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
- Trial name
- NCT03343535
- Testing
- OCS Lung Preservation
- Where
- 14 sites in United States
- Volunteers
- 46 people
- Sponsor
- TransMedics
Respiratory Syncytial Virus (RSV)
Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
The primary objective of this study is to evaluate the effect of presatovir on nasal respiratory syncytial virus (RSV) viral load in RSV-positive lung transplant (LT) recipients with acute respiratory symptoms.
- Trial name
- NCT02534350
- Testing
- Presatovir
- Where
- 28 sites in United States, Australia and 6 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Lung Diseases
Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end…
- Trial name
- NCT03641677
- Testing
- Centralized Lung Evaluation System, Lung Transplant
- Where
- 13 sites in United States
- Volunteers
- 174 people
- Sponsor
- Lung Bioengineering Inc.
Chronic Graft Versus Host Disease
Extracorporeal Photopheresis (ECP) With Methoxsalen for Chronic Graft Versus Host Disease (cGVHD)
Chronic graft-versus-host disease (cGVHD) is a long-lasting complication that can occur after transplants. The transplanted cells seem to fight with the patient's own cells.
- Trial name
- NCT01380535
- Testing
- ECP Methoxsalen, Standard of Care
- Where
- 32 sites in United States, Austria and 6 more
- Volunteers
- 60 people
- Sponsor
- Mallinckrodt
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
Respiratory Syncytial Virus Infections
A Study on the Immune Response and Safety of an RSV Vaccine When Given to Adults 18 Years of Age and Above Who Received Lung or Kidney Transplant and Are at an Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease and Compared to Healthy Adults 50 Years of Age and Above
The purpose of this study is to evaluate the immunogenicity, safety, and reactogenicity of the RSVPreF3 OA investigational vaccine in an immunocompromised (lung and renal transplant recipients) population and assess whether a…
- Trial name
- RSV OA=ADJ-023 (NCT05921903)
- Testing
- RSVPreF3 OA Investigational Vaccine
- Where
- 46 sites in United States, Australia and 6 more
- Volunteers
- 386 people, healthy volunteers welcome
- Sponsor
- GlaxoSmithKline
Lung Preservation
International Randomized Study of the TransMedics Organ Care System (OCS Lung) for Lung Preservation and Transplantation
A prospective, international, multi-center, randomized controlled trial comparing preservation of donor lungs using OCS-Lung perfusion device (Treatment Group) to cold flush and storage (Control Group).
- Trial name
- INSPIRE (NCT01630434)
- Testing
- OCS Lung, Cold flush and storage
- Where
- 21 sites in United States, Australia and 7 more
- Volunteers
- 320 people
- Sponsor
- TransMedics
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
Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis
EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
The purpose of this study is to assess the efficacy and safety of the study drug, known as "ATG Fresenius S," which is sometimes called "EZ-2053," to prevent a lung transplant patient's body from rejecting a transplanted lung or…
- Conditions
- Chronic Obstructive Pulmonary, Idiopathic Pulmonary Fibrosis, Cystic Fibrosis, Bronchiectasis
- Trial name
- NCT00105183
- Testing
- EZ-2053, EZ-2053 5mg/kg
- Where
- 19 sites in United States, Australia and 2 more
- Volunteers
- 223 people
- Sponsor
- Neovii Biotech
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
Chronic Graft Versus Host Disease
Efficacy and Tolerability of Entospletinib in Combination With Systemic Corticosteroids as First-Line Therapy in Adults With Chronic Graft Versus Host Disease (cGVHD)
The primary objective of this study is to evaluate the effect of entospletinib (ENTO) on the best overall response rate in adults with chronic graft versus host disease (cGVHD) who are currently receiving systemic corticosteroids…
- Trial name
- NCT02701634
- Testing
- ENTO
- Where
- 30 sites in United States, Canada and 5 more
- Volunteers
- 66 people
- Sponsor
- Gilead Sciences
Portopulmonary Hypertension, Pulmonary Arterial Hypertension
A Study to Assess the Safety and Efficacy of Treprostinil to Facilitate Liver Transplantation in Patients With Portopulmonary Hypertension
This was a multicenter, prospective, observational, open-label study. Patients meeting inclusion/exclusion criteria received treatment with treprostinil as recommended by their treating physicians and were followed according to…
- Conditions
- Portopulmonary Hypertension, Pulmonary Arterial Hypertension, Pulmonary Hypertension
- Trial name
- NCT01028651
- Testing
- Treprostinil
- Where
- 4 sites in United States
- Volunteers
- 13 people
- Sponsor
- United Therapeutics
Lung Disease
Extending Preservation and Assessment Time of Donor Lungs Using the Toronto EVLP System™ at a Dedicated EVLP Facility
This is a safety study to compare the safety of receiving a lung treated with the Toronto EVLP System™ by SPONSOR in SPONSOR's dedicated facility against standard lung transplantation.
- Trial name
- NCT02234128
- Testing
- Toronto EVLP System™
- Where
- 8 sites in United States
- Volunteers
- 118 people
- Sponsor
- Lung Bioengineering Inc.
Lung Transplantation
Efficacy Regarding Renal Function of Everolimus in Combination With Specific Standard Immunosuppressive Regimen Lung Transplant Recipients
This trial evaluated the efficacy of an everolimus-based quadruple low immunosuppressive regimen versus a standard immunosuppressive regimen concerning kidney function in lung transplant recipients.
- Trial name
- 4EVERLUNG (NCT01404325)
- Testing
- standard therapy, Everolimus
- Where
- 9 sites in Germany
- Volunteers
- 130 people
- Sponsor
- Novartis Pharmaceuticals
Fungal Infection
A Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients (MK-5592-105)
This single site study will examine plasma and alveolar compartment (AC) levels of posaconazole in cystic fibrosis (CF) and non-cystic fibrosis (non-CF) lung transplant recipients receiving routine post-operative anti-fungal…
- Trial name
- PAPAL (NCT01667107)
- Testing
- Posaconazole, Calogen®
- Volunteers
- 26 people
- Sponsor
- Merck Sharp & Dohme LLC
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