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NCT03473340 · ClinicalTrials.gov registry record · Phase 2
Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)
A Phase 2 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
NCT03473340: Clinical Trial Phase 2 study, sponsored by University of Michigan.
NCT03473340 is a Phase 2 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 24 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03473340, a Phase 2 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
Study Summary
Greater than 50% of lung transplant recipients show signs of chronic lung allograft dysfunction (CLAD) by 5 years post-transplantation.Therapies to prevent or slow CLAD are lacking. Anti-fibrotic therapies may offer an avenue to prevent progression of CLAD and prolong allograft survival. This study investigates if Pirfenidone therapy will stabilize lung function decline and slow progression of Functional small airways disease (fSAD) in lung transplant recipients with CLAD.
Primary Outcome
Evaluate if pirfenidone compared to placebo will stabilize progression of fSAD by comparison of inspiratory and expiratory high resolution computed tomography (HRCT) images through co-registration to provide quantitative measures of fSAD.
Interventions
- DRUG Placebo Capsule
- DRUG Pirfenidone Capsule
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2018-04-27 |
| Est. Completion | 2021-08-20 |
| Phase | Phase 2 |
Why NCT03473340 stopped before completion
NCT03473340 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (82% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo Capsule is the first listed.
NCT03473340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03473340 about?
NCT03473340 is a clinical study titled "Studying the Treatment Effect of Pirfenidone in Chronic Lung Allograft Dysfunction (STOP-CLAD)". Greater than 50% of lung transplant recipients show signs of chronic lung allograft dysfunction (CLAD) by 5 years post-transplantation.Therapies to prevent or slow CLAD are lacking. Anti-fibrotic therapies may offer an avenue to prevent progression of CLAD and prolong allograft survival. This study ...
What is the current status of trial NCT03473340?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2018-04-27. Estimated completion is 2021-08-20.
What interventions are being tested in trial NCT03473340?
The interventions under investigation include: Placebo Capsule (DRUG), Pirfenidone Capsule (DRUG).
Who is sponsoring clinical trial NCT03473340?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03473340's enrollment target sits among peer trials
24 1756th of 2000 higher than 217 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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