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NCT06018766 · ClinicalTrials.gov registry record · Phase 2
LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.
A Phase 2 study of Lung Transplantation and Bronchiolitis Obliterans Syndrome, sponsored by Steven Hays, MD.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06018766 is a Phase 2 study of Lung Transplantation and Bronchiolitis Obliterans Syndrome that is actively recruiting participants, run by Steven Hays, MD. The registered enrollment target is 30 participants, below the 334-participant average among 12 other Lung Transplantation trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06018766, a Phase 2 study of Lung Transplantation and Bronchiolitis Obliterans Syndrome, is actively recruiting participants, sponsored by Steven Hays, MD.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: * Is LAM-001 safe in these patients? * Is LAM-001 effective in slowing BOS progression? Participants will: * Be randomly assigned to inhale either LAM-001 or placebo (a look-alike substance that contains no active drug) daily for 48 weeks * Attend 10 study visits (mixture of in-person and telehealth) over the 48 week period * Undergo pulmonary function testing, bronchoscopy, lab testing, and physical examination * Submit weekly home spirometry monitoring Researchers will compare participants assigned to LAM-001 versus placebo to see if LAM-001 is safely tolerated and to assess the effectiveness of LAM-001 on slowing BOS progression.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG LAM-001
Study Locations (1)
California
- University of California, San Francisco - San Francisco
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2023-08-17 |
| Est. Completion | 2026-10 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06018766
The ClinicalTrials.gov registry entry for NCT06018766 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 334-participant average among 12 other Lung Transplantation trials with a reported enrollment target (91% lower). The listed sponsor is Steven Hays, MD, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Lung Transplantation appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06018766 reports 1 study location spanning 1 distinct geographic area - top geographies include California.
Frequently Asked Questions
What is clinical trial NCT06018766 about?
NCT06018766 is a clinical study titled "LAM-001 in Lung Transplant Recipients With Bronchiolitis Obliterans Syndrome.". The goal of this clinical trial is to learn about the safety and effectiveness of LAM-001 in patients who have developed bronchiolitis obliterans syndrome (BOS), a form of chronic rejection, after lung transplantation. The main questions it aims to answer are: * Is LAM-001 safe in these patients? ...
What is the current status of trial NCT06018766?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2023-08-17. Estimated completion is 2026-10.
What conditions does trial NCT06018766 study?
This clinical trial studies the following conditions: Lung Transplantation, Bronchiolitis Obliterans Syndrome, Chronic Lung Allograft Dysfunction.
What interventions are being tested in trial NCT06018766?
The interventions under investigation include: Placebo (DRUG), LAM-001 (DRUG).
Who is sponsoring clinical trial NCT06018766?
This trial is sponsored by Steven Hays, MD, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06018766 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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