Clinical trials: Lung Transplantation
Lung Neoplasms, Disorder Related to Lung Transplantation
Registry Trial to Determine pCLE Image Interpretation Criteria and Preliminary Accuracy in the Lung
Patients will be enrolled that are undergoing bronchoscopy for diagnosis of discrete lung lesions or for detection of acute rejection following lung transplants.
- Trial name
- BREATH (NCT01793246)
- Testing
- probe based laser endomicroscopy (pCLE)
- Where
- 9 sites in United States
- Volunteers
- 99 people
- Sponsor
- Mauna Kea Technologies
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
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
Congenital Heart Disease
TORCH-LATAM: A Regional Pathway to Improve Transplant Evaluation for Congenital Heart Disease
Congenital heart disease can progress to advanced cardiac or cardiopulmonary failure requiring heart, heart-lung, or, in selected congenital conditions, bilateral lung transplantation with cardiac repair.
- Trial name
- TORCH-LATAM (NCT07799272)
- Testing
- TORCH Integrated Transplant Access Pathway (TORCH-ITAP)
- Volunteers
- 600 people
- Sponsor
- CardioVision International Tech, S.A.S. de C.V.
Lung Transplant Rejection
An Open Label Trial Evaluating the Safety, Tolerability, Efficacy and Pharmacokinetic Profile of Tacrolimus Inhalation Powder in Adult Lung Transplant Recipients
Part A: This is an open label, single-arm study that will evaluate the safety, tolerability, efficacy and PK of Tacrolimus Inhalation Powder over 12 weeks in lung transplant patients who require reduced blood levels of tacrolimus…
- Trial name
- NCT05501574
- Testing
- Tacrolimus Inhalation Powder, Plastiape RS00 Dry Powder inhaler device
- Where
- 2 sites in Australia
- Volunteers
- 14 people
- Sponsor
- TFF Pharmaceuticals, Inc.
Ischemia-Reperfusion Injury
Inhaled Nitric Oxide in Prevention/Treatment of Ischemia-Reperfusion Lung Injury Related to Lung Transplantation
The purpose of this study is to evaluate the effects of inhaled nitric oxide on both short-term physiology as well as on the development of ischemia-reperfusion lung injury (IRLI) in the immediate post transplant period.
- Trial name
- NCT00060450
- Testing
- nitric oxide for inhalation
- Where
- United States
- Volunteers
- 84 people
- Sponsor
- Mallinckrodt
Lung Transplantation
Normothermic Ex Vivo Lung Perfusion (EVLP) For An Improved Assessment of Donor Lungs For Transplantation
The use of ex vivo lung perfusion (EVLP) will allow for a secondary evaluation technique for donor lungs that fail to meet standard acceptability criteria.
- Trial name
- HELP (NCT01190059)
- Testing
- Ex vivo lung perfusion with Steen Solution™
- Where
- Canada
- Volunteers
- 22 people
- Sponsor
- XVIVO Perfusion
Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans)
A Rollover Study to Provide Continued Treatment for Participants Previously Enrolled in Studies of Itacitinib
This is a mutli-center open-label study to provide continued supply of itacitinib to participants from the following Incyte-sponsored studies of itacitinib: INCB39110-209, INCB39110-213, INCB39110-214, INCB39110-230, and…
- Conditions
- Myelofibrosis, Postlung Transplant (Bronchiolitis Obliterans), Chronic Graft Versus Host Disease
- Trial name
- NCT04640025
- Testing
- itacitinib
- Where
- 21 sites in United States, Austria and 7 more
- Volunteers
- 18 people
- Sponsor
- Incyte Corporation
Graft Rejection, Lung Disease
Lung Allograft Rejection Gene Expression Observational (LARGO) Study
The objective of the LARGO Study protocol is to collect peripheral blood samples, select associated lung biopsy pathology slides, and clinical data from lung transplant recipients to perform molecular analyses in association with…
- Trial name
- LARGO (NCT00751309)
- Testing
- Non-interventional
- Where
- 20 sites in United States, Austria and 3 more
- Volunteers
- 2,044 people, healthy volunteers welcome
- Sponsor
- XDx
Lung Transplant Rejection
Analysis of Volatile Organic Compounds in the Breath of Lung Transplant Rejection Patients Using Infrared Spectroscopy
This study will sample and analyze volatile organic compounds (VOCs) from participants considered to be at risk for developing rejection following lung transplant by using infrared spectroscopy.
- Trial name
- NCT06309628
- Testing
- Breathe sample
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Paragonix Technologies
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
Non-Melanoma Skin Carcinoma
Evaluation Of The Importance Of Risk-Factor Adjustment For Assessing The Relationship Between Voriconazole Utilization And The Development Of Non-Melanoma Skin Cancer Among Lung And Heart/Lung Transplant Patients, 2002-2009g
The primary objective of the study is to assess the relationship (both crude and adjusted) between voriconazole utilization and the development of non-melanoma skin cancer among adult patients who received a lung or heart/lung…
- Trial name
- NCT01480219
- Testing
- voriconazole (Vfend), no voriconazole (Vfend)
- Volunteers
- 467 people
- Sponsor
- Pfizer
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
Chronic Respiratory Disease
Autologous Bronchial Basal Cells Transplantation for Treatment of CRD Including COPD, BE and PF
Chronic respiratory diseases including chronic obstructive pulmonary disease (COPD), bronchiectasis (BE) or pulmonary fibrosis (PF) are usually not curable with damaged pulmonary structure and function.
- Trial name
- NCT03153800
- Testing
- bronchial basal cells
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Regend Therapeutics
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
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
Lung Transplant
CIS001 Extension Study of Cyclosporine Inhalation Solution
This trial is a longterm follow up of a phase III study of inhaled cyclosporine for the prevention of chronic rejection in lung transplant recipients.
- Trial name
- CIS002 (NCT00938236)
- Testing
- Cyclosporine Inhalation Solution (CIS)
- Where
- 16 sites in United States, Canada
- Volunteers
- 17 people
- Sponsor
- APT Pharmaceuticals, Inc.
Chronic Allograft Dysfunction
Study of STX-100 in Renal Transplant Patients With Interstitial Fibrosis and Tubular Atrophy (IF/TA)
This Phase 2 study is a multi-center, randomized, double-blind, placebo-controlled, single followed by multiple dose, dose escalation study designed to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and…
- Trial name
- NCT00878761
- Testing
- STX-100
- Where
- United States
- Volunteers
- 48 people
- Sponsor
- Stromedix, Inc.
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
Heart Transplantation, Lung Transplantation
Study to Compare the Pharmacokinetics of Tacrolimus in Adult Transplant Recipients Treated With Advagraf® or Prograf®
Comparison of tacrolimus blood levels in adults who have received a transplant and are taking either Prograf or Advagraf anti-rejection therapy immediately following surgery.
- Conditions
- Heart Transplantation, Lung Transplantation, Pancreas (Including SPK) Transplantation
- Trial name
- NCT01332201
- Testing
- Advagraf, Prograf
- Where
- 8 sites in Austria, Belgium and 4 more
- Volunteers
- 17 people
- Sponsor
- Astellas Pharma Inc