The Safety and Tolerability of Pirfenidone for BOS After HCT
NCT03315741 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30
Last updated 2022-06-13
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.
Conditions
- Bronchiolitis Obliterans
- Graft Vs Host Disease
Interventions
- DRUG
-
Pirfenidone 267 MG [Esbriet]
Tolerability of drug
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY - lead OTHER
Principal Investigators
-
Joe L Hsu, MD, MPH · Stanford University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-03-01
- Primary Completion
- 2022-02-27
- Completion
- 2022-04-27
- FDA Drug
- Yes
Countries
- United States
Study Locations
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