PiMZ Longitudinal Cohort (PiMZ Logic)
NCT06505603 · Alpha 1-Antitrypsin Deficiency, Emphysema or COPD
RecruitingAlpha-1 Anti-trypsin Deficiency (AATD) is a genetic disease with lung and liver disease presentations. Presentations are variable in the heterozygous population, the most predominant genotype being PiMZ. The purpose of this study in PiMZ heterozygous patients is to examine the density of the lung as measured by chest computed tomography (CT) and determine if existing emphysema predicts changes in the rate of subsequent emphysema or changes in CT, serum or plasma biomarkers of interest. The overarching goal is to develop biomarkers pertinent to the PiMZ patient that can be used in interventional trials since lung function changes do not typically inform disease progression in AATD.
Phase—
TypeObservational
Age18 Years
WhereBirmingham, Alabama, United States + 4 more
SponsorColumbia University
▾Tap for detailsClick for full details — eligibility, all locations, contacts Multi-Center Clean Air Randomized Controlled Trial in COPD
NCT06376994 · Chronic Obstructive Pulmonary Disease (COPD)
RecruitingThis is a multi-center randomized, sham-controlled clinical trial to determine the effectiveness of an air cleaner intervention aimed at improving indoor air quality on reducing COPD exacerbation risk and improving quality of life, functional status, rescue medication use.
PhasePhase 3
TypeInterventional
Age40 Years
WhereBirmingham, Alabama, United States + 10 more
SponsorJHSPH Center for Clinical Trials
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Long-term Extension Study of PCI-32765 (Ibrutinib)
NCT01804686 · Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma
RecruitingThe purpose of this study is to collect long-term safety and efficacy data for participants treated with ibrutinib and to provide ongoing access to ibrutinib for participants who are currently enrolled in ibrutinib studies that have been completed according to the parent protocol, are actively receiving treatment with ibrutinib, and who continue to benefit from ibrutinib treatment.
PhasePhase 3
TypeInterventional
Age18 Years
WhereDuarte, California, United States + 173 more
SponsorJanssen Research & Development, LLC
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study to Evaluate the Safety and Efficacy of Axatilimab in Combination With Ruxolitinib in Participants With Newly Diagnosed Chronic Graft-Versus-Host Disease
NCT06388564 · Chronic Graft-versus-host-disease
RecruitingThis study will be conducted to determine the preliminary efficacy of axatilimab in combination with ruxolitinib and to assess the contribution of axatilimab to the combination treatment effect in participants with cGVHD.
PhasePhase 2
TypeInterventional
Age12 Years
WherePhoenix, Arizona, United States + 69 more
SponsorIncyte Corporation
▾Tap for detailsClick for full details — eligibility, all locations, contacts SPIROMICS Study of Early COPD Progression (SOURCE)
NCT05033990 · COPD, Early-Onset
RecruitingThis is an observational study of 1000 participants to further define the nature of early chronic obstructive pulmonary disease (COPD) in younger, at-risk individuals. The study has three main goals: * To use CT scan imaging to identify which smokers will develop COPD. * To identify biomarkers predictive of smokers that will develop COPD. * To determine if sputum (phlegm) can be analyzed to predict which smokers will develop COPD. Procedures (methods): All participants will undergo study related questionnaires assessing medical history, smoke exposure and use, medication use, social and behavioral health, pulmonary symptoms, food frequency, and will provide nasal swab, blood, stool, and urine samples, pulmonary function testing to determine function, sputum induction to provide a sputum sample for airway biospecimen analysis, and CT imaging of the lungs.
Phase—
TypeObservational
Age30 Years – 55 Years
WhereBirmingham, Alabama, United States + 13 more
SponsorUniversity of Massachusetts, Worcester
▾Tap for detailsClick for full details — eligibility, all locations, contacts A Study of Belumosudil in Children With Chronic Graft Versus Host Disease (schoolROCK)
NCT07116031 · Chronic Graft Versus Host Disease
RecruitingThis is an open-label, single group, Phase 1/2, 1-arm study for treatment of children aged 1 to \<18 years with active moderate-to-severe cGVHD that is refractory to or recurred after at least 2 prior lines of systemic therapy for cGVHD. The purpose of Phase 1 is to determine the PK profiles and to establish the Recommended Pediatric Equivalent Dose (RPED) of belumosudil in participants aged 1 to \<12 years with active moderate to severe cGVHD. Upon completion and evaluation of Phase 1, Phase 2 will commence with the purpose of determining safety and efficacy (ORR by 24 weeks) of belumosudil in participants aged 1 to \<18 years. Study details include: The end of study is defined as 3 years after the last participant is recruited or all participants have discontinued treatment, or have died, whichever comes first. Minimum of 6 participants ages 1 to 6 years will be enrolled for each phase of study Individual participant duration on study will consist of: Up to 4 weeks for screening. Treatment until clinically significant progression of cGVHD, relapse/recurrence of the underlying disease, start of a new systemic treatment for cGVHD, experience of an unacceptable adverse event, request from participant or Investigator, or until the end of the study is reached, whichever comes first. 4 weeks of post treatment safety follow-up. Long-term follow-up until death or end of study, whichever occurs first.
PhasePhase 2
TypeInterventional
Age1 Year – 18 Years
WhereLos Angeles, California, United States + 27 more
SponsorSanofi
▾Tap for detailsClick for full details — eligibility, all locations, contacts Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
NCT06476132 · Lung Transplant
RecruitingThe purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD. The primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death.
PhasePhase 2
TypeInterventional
Age12 Years
WhereLos Angeles, California, United States + 11 more
SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
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