Phase 2 N=11 Intravenous Immunoglobulin (IVIG) in Lung Transplantation
Hypogammaglobulinemia · Lung Transplantation
Primary: Number of Clinically Diagnosed Bacterial Infections During the Treatment Period — 3; 1 Infections
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N/A N=133 Immunoglobulin Levels and Occurrence of Infections After Lung Transplantation and Impact of IgG Replacement
Infections After Lung Transplant
Primary: The Primary Outcome Will be the Total Number of Days With Pneumonia. — 1714; 51 Number of days
Phase 2 N=32 Preliminary Study of Dornase Alfa to Treat Chest Infections Post Lung Transplant.
Lung Transplant Infection · Lower Respiratory Tract Infection
Primary: Lung Clearance Index 2% (LCI2%) — 10.68; 11.65; 10.09; 11.19 Index (change)
Phase 2 N=16 Inhaled Beclomethasone After Community-Acquired Respiratory Viral Infection in Lung Transplant Recipients
Lung Transplant Infection
Primary: Number of Participants Free From New or Progressive Chronic Lung Allograft Dysfunction — 2; 4 Participants
Phase 2 N=23 Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans Syndrome
Constrictive Bronchiolitis · Bronchiolitis Obliterans · Graft vs Host Disease
Primary: Overall Response to Treatment Based on Positive Response to Cyclosporine Inhalation Solution (CIS) — 9; 0 Participants
N/A N=88 Lung Transplant G0 (LTGO): Improving Self-Management of Exercise After Lung Transplantation
Exercise · Lung Transplantation
Primary: Physical Function- Walking: Change in Average Steps Per Day at Month 3 — 460; 352 average steps per day — p=0.8793
Phase 2 N=64 Envarsus XR in Lung Transplant
Lung Transplant
Primary: Percentage of Patients Remaining on Envarsus XR at 1 Year — 40 Participants
Phase 2 N=45 B Cell Induction in Pediatric Lung Transplantation
Lung Transplant
Primary: Earliest Time to Any of the Following Events: Chronic Allograft Dysfunction, Listed for Retransplant or Death — NA; 703 Days — p=0.514
Phase 2 N=20 Hyperbaric Oxygen Therapy for Lung Transplantation
Disorder Related to Lung Transplantation · Central Airway Stenosis · Airway Exudative Plaques
Primary: Subjects Needing Airway Stent Placement as Determined by Transbronchial Lung Biopsy. — 4; 4 Participants — p=1
Phase 2 N=27 Belatacept Pilot Study in Lung Transplantation Immunosuppression in Lung Transplantation
Lung Transplant Rejection · Antibody-mediated Rejection
Primary: Donor-specific HLA Antibodies, Re-transplantation, or Death — 0; 5; 3; 3 participants
Phase 2 N=61 Presatovir in Lung Transplant (LT) Recipients With Respiratory Syncytial Virus (RSV) Infection
Respiratory Syncytial Virus (RSV)
Primary: Time-Weighted Average Change in Viral Load From Day 1/Baseline Through Day 7 in Participants in the Full Analysis Set — -0.73; -0.90 log10 copies/mL — p=0.72
Phase 2 N=15 Letermovir for CMV Prevention After Lung Transplantation
Lung Transplant · CMV
Primary: Occurrence of CMV Infection or Disease During Prophylaxis — 0 Participants
Phase 2 N=10 Pirfenidone for Restrictive Chronic Lung Allograft Dysfunction
Restrictive Chronic Lung Allograft Dysfunction · Lung Transplant Rejection
Primary: Tolerability of Pirfenidone — 3 Participants
Phase 3 N=68 A Study of Mycophenolate Mofetil (CellCept) in Lung Transplant Recipients
Lung Transplantation
Primary: Maximum Concentration (Cmax) of Mycophenolic Acid (MPA), Mycophenolic Acid Glucuronide (MPAG) and Acyl Glucuronide Metabolite of Mycophenolic Acid (AcMPAG) at Day 4…
Phase 2 N=5 Bilateral Orthotopic Lung Transplant - Bone Marrow Transplant
Primary Immunodeficiency · PID
Primary: Safety: Death — 4 Participants
Phase 4 N=83 Azithromycin in Bronchiolitis Obliterans Syndrome
Bronchiolitis Obliterans Syndrome · Graft Rejection · Lymphocytic Bronchiolitis
Primary: Prevalence of Bronchiolitis Obliterans Syndrome (BOS) — 5; 19 participants
N/A N=52 Lung Transplant READY Pilot Study
Cystic Fibrosis
Primary: Feasibility of Participants Completing 2-week Study Visit — 25; 25; 0 Participants
Phase 2 N=10 Transplanting Hepatitis C Lungs Into Negative Lung Recipients
Lung Diseases
Primary: Subject Sustained Virologic Response (SVR-12) at 12-weeks Post-treatment — 10 Participants
Phase 4 N=181 Comparison of Sirolimus and Azathioprine in Lung Transplantation
Delayed Graft Function · Acute Graft Rejection
Primary: Acute Rejection Rate at 12 Months — 48; 39 percentage of participants
N/A N=10 Effects of Mycophenolate Mofetil in Cystic Fibrosis Lung Transplant Patients
Cystic Fibrosis · Lung Transplant
Primary: Steady-state Pharmacokinetics of Mycophenolic Acid and Mycophenolic Acid Glucuronide in Stable Cystic Fibrosis and Non-Cystic Fibrosis Lung Transplant Recipients…
Phase 2 N=20 A Study of the Use of Hepatitis C Positive Donors for Hepatitis C Negative Lung Transplant Recipients With Post-transplant Treatment With Mavyret
Hepatitis C
Primary: Number of Incidences of Viremia After Receiving a Lung Transplant From a Donor Who Tests Positive for Hepatitis C — 16 incidences
Phase 2 N=114 Repertaxin in Prevention of Primary Graft Dysfunction After Lung Transplantation
Ischemia-Reperfusion Injury · Lung Transplantation
Primary: PaO2/FiO2 Ratio at ICU Admission (Time 0) and 24 Hours — 346.3; 337.9; 320.1; 307.3 ratio of PaO2/FiO2 — p=0.8541
N/A N=49 FOB in HSCT and Leukemia Patients With Acute Respiratory Symptoms and Pulmonary Infiltrates
Pulmonary Infiltrate New
Primary: Number of Patients With Positive Culture or Molecular Results After Brochoscopy — 40 participants
Phase 2 N=7 Extension Study (Extended Access) of Cyclosporine Inhalation Solution (CIS) in Lung Transplant and Hematopoietic Stem Cell Transplant Recipients for the Treatment of Bronchiolitis Obliterans
Bronchiolitis Obliterans · Constructive Bronchiolitis · Graft Versus Host Disease
Primary: Improvement in Lung Function - Increase in FEV1 — 0 Participants
Phase 2 N=21 Aerosol Liposomal Cyclosporine for Chronic Rejection in Lung Transplant Recipients
Disorder Related to Lung Transplantation · Bronchiolitis Obliterans · Decreased Immunologic Activity
Primary: Number Of Participants With Chronic Rejection Who Met Primary Combined End-point — 2; 5 Participants — p=0.03
N/A N=15 Assessment of Cough Reflex in Lung Transplant Recipients
Complication of Transplanted Lung
Primary: Number of Coughs — 7.3 Coughs — p=<0.01
Phase 3 N=102 Surgical Site Infections After Liver Transplantation Based on Perioperative Antibiotics
Liver Transplantation · Surgical Site Infection
Primary: Number of Subjects With Development of Surgical Site Infections — 9; 13 Participants
Phase 3 N=136 Comparison of Oral Valganciclovir and Placebo for the Prevention of Cytomegalovirus (CMV) After Lung Transplantation
Cytomegalovirus Infections
Primary: Incidence of CMV End Organ Disease — 21; 1 participants
Phase 3 N=223 EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection
Chronic Obstructive Pulmonary · Idiopathic Pulmonary Fibrosis · Cystic Fibrosis
Primary: Number of Participants With the Event Death, Graft Loss, Acute Rejection and/or Loss to Follow-up (Whichever Occurred First) — 33; 29; 30 participants
Phase 4 N=45 Voriconazole for Secondary Prophylaxis of Invasive Fungal Infections in Patients With Allogeneic Stem Cell Transplants
Prophylaxis Of Invasive Fungal Infections
Primary: Occurrence of Proven or Probable Invasive Fungal Infection (IFI): Start of Prophylaxis Until 12-month Follow-up Visit — 3 participants