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NCT03315741 · ClinicalTrials.gov registry record · Phase 1
The Safety and Tolerability of Pirfenidone for BOS After HCT
A Phase 1 study, sponsored by Stanford University.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT03315741: Completed Phase 1 study, sponsored by Stanford University.
NCT03315741 is a Phase 1 study that has completed, run by Stanford University. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03315741, a Phase 1 study, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant.
Primary Outcome
We will count the number of participants that do not require a reduction in drug dose of more than 21, non-continuous days due to adverse events. Tolerability will be assessed during continuous treatment. If the medication dosage increase results in the reoccurrence of a moderate adverse event or serious adverse event, lasting more than 21 days, then the event would be defined as "not tolerated". If adverse events resolve before 21 days, then participants will attempt to again up-titrate the Pir
Interventions
- DRUG Pirfenidone 267 MG [Esbriet]
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2018-03-01 |
| Est. Completion | 2022-04-27 |
| Phase | Phase 1 |
What the finished NCT03315741 record still lists
NCT03315741 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Pirfenidone 267 MG [Esbriet] is the first listed.
NCT03315741 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03315741 about?
NCT03315741 is a clinical study titled "The Safety and Tolerability of Pirfenidone for BOS After HCT". This is a phase 1, non-randomized, single-arm, open label, single center clinical trial to determine the tolerability and safety of pirfenidone in patients with BOS associated with lung GVHD after hematopoietic cell transplant.
What is the current status of trial NCT03315741?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2018-03-01. Estimated completion is 2022-04-27.
What interventions are being tested in trial NCT03315741?
The interventions under investigation include: Pirfenidone 267 MG [Esbriet] (DRUG).
Who is sponsoring clinical trial NCT03315741?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03315741's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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