Clinical trials: Transplantation Lung
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.
Fecal Microbiota Transplantation
Metabonomics of COPD and Transplanting of Faecal Bacteria in the Treatment of Its Malnutrition
Oxidative stress can affect the balance of intestinal flora and intestinal structure of patients, resulting in intestinal flora disorder.
- Trial name
- NCT04861649
- Testing
- fecal microbiota transplantation
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Asclepius Meditec Inc.
Chronic Obstructive Airway Disease
Clinical Study to Investigate Safety and Performance of NeuRx DPS in Patients Undergoing Bilateral Lung Transplantation
This study is a prospective, single-center feasibility study to acquire more knowledge regarding the NeuRx DPS and develop a routine in the optimal pacing of the diaphragm with this system during the weaning period from…
- Trial name
- NCT02411383
- Testing
- NeuRx Diaphragm Pacing System
- Where
- Belgium
- Volunteers
- 4 people
- Sponsor
- Synapse Biomedical
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.
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.
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
Cancer Metastatic to the Liver, Hepatocellular Carcinoma
A Study to Assess PV-10 Chemoablation of Cancer of the Liver
This open-label study will evaluate the safety, tolerability, pharmacokinetics and effect on tumor growth following a single intralesional injection of PV-10 in subjects with either (a) hepatocellular carcinoma (HCC) that is not…
- Conditions
- Cancer Metastatic to the Liver, Hepatocellular Carcinoma, Metastatic Melanoma, Metastatic Ocular Melanoma
- Trial name
- NCT00986661
- Testing
- PV-10 (10% rose bengal disodium)
- Where
- 5 sites in United States
- Volunteers
- 78 people
- Sponsor
- Provectus Biopharmaceuticals, Inc.
Heart and Lung Transplant
Nordic Study in Cardiac and Lung Transplantation: Outcome in Relation to Cyclosporine Microemulsion C2 Levels
The main purpose of this study is to identify cyclosporine C2 levels during 12 months treatment , while cyclosporine microemulsion dosages are adjusted based on C0 cyclosporine blood samples, and retrospectively correlate C2…
- Trial name
- NCT00154193
- Testing
- cyclosporine
- Where
- Switzerland
- Volunteers
- 190 people
- Sponsor
- Novartis Pharmaceuticals
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.
Bronchiolitis Obliterans Syndrome
Safety and Efficacy of Itacitinib in Participants With Bronchiolitis Obliterans Syndrome Following Lung Transplantation
The purpose of this study is to evaluate the safety, efficacy, pharmacokinetics, and pharmacodynamics of itacitinib in participants with post-lung transplant bronchiolitis obliterans syndrome (BOS).
- Trial name
- NCT03978637
- Testing
- Itacitinib
- Where
- 9 sites in United States, Belgium and 1 more
- Volunteers
- 23 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
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
Respiratory Syncytial Virus Infections
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
To evaluate the efficacy and safety of ALN-RSV01 plus standard of care in RSV infected lung transplant patients
- Trial name
- NCT01065935
- Testing
- ALN-RSV01, Normal Saline
- Where
- 33 sites in United States, Australia and 4 more
- Volunteers
- 87 people
- Sponsor
- Alnylam Pharmaceuticals
Lung Transplant Rejection
Assessment of Chronic Lung Allograft Dysfunction Using Single-breath & Multi-breath Hyperpolarized Xenon-129 MRI
This study will use Magnetic Resonance Imaging (MRI) to study the lungs of 90 volunteers using the inhaled contrast agent, hyperpolarized xenon-129.
- Trial name
- NCT04941573
- Testing
- Hyperpolarized 129-Xenon (MagniXene) MRI of the lung
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Xemed LLC
Lung Transplant
Cyclosporine Inhalation Solution (CIS) in Lung Transplant Recipients
Currently there are no approved therapies for lung transplant recipients in the United States (US). Treatment with CIS following lung transplantation has previously been demonstrated to result in a clinically meaningful…
- Trial name
- NCT00633373
- Testing
- Cyclosporine Inhalation Solution
- Where
- 8 sites in United States
- Sponsor
- APT Pharmaceuticals, Inc.
Lung Transplant
Novel Lung Trial: Normothermic Ex Vivo Lung Perfusion (Evlp) As An Assessment Of Extended/Marginal Donor Lungs
Human donor lungs that do not meet the standard clinical criteria for donor lung utilization but fit into the study inclusion criteria will be retrieved from the donor using current donor lung retrieval techniques.
- Trial name
- NCT01365429
- Testing
- XPS™ with Steen Solution™
- Where
- 18 sites in United States
- Volunteers
- 252 people
- Sponsor
- XVIVO Perfusion
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
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
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
Melanoma Stage IV, Unresectable Melanoma
A Phase Ib Trial to Evaluate the Safety and Efficacy of FMT and Nivolumab in Subjects With Metastatic or Inoperable Melanoma, MSI-H, dMMR or NSCLC
A Phase Ib trial to evaluate the safety and efficacy of Fecal Microbial Transplantation (FMT) in combination with Nivolumab in subjects with metastatic or inoperable melanoma, microsatellite instability-high (MSI-H) or…
- Conditions
- Melanoma Stage IV, Unresectable Melanoma, NSCLC Stage IV
- Trial name
- NCT04521075
- Testing
- Fecal Microbial Transplantation by capsules
- Where
- Israel
- Volunteers
- 42 people
- Sponsor
- Ella Therapeutics Ltd