The Safety and Tolerability of Pirfenidone for BOS After HCT (NCT03315741) | Clinical Trial Compass
CompletedPhase 1
The Safety and Tolerability of Pirfenidone for BOS After HCT
United States30 participantsStarted 2018-03-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age \> 18 years at randomization
✓. Clinical symptoms (e.g., dyspnea or cough) consistent with BOS of ≥ 2 months duration
✓. Presence of cGVHD in an organ other than lung
✓. Subjects must have had recent pulmonary function test (PFTs) measured for at least 3 months prior to study enrollment that show:
✓. A decrease in %FVC and/or %FEV1 ≥ 20% at Screening compared with pre-transplant baseline.
✓. Bronchodilator response on PFT testing that results in an FEV1 \< 75%
✓. Diagnosis of BOS by one of the following criteria:
✓. Transbronchial or surgical lung biopsy demonstrating the obliterative bronchiolitis lesion
Exclusion criteria
✕. Any condition that, in the opinion of the investigator, might be significantly exacerbated by the known side effects associated with the administration of pirfenidone e.g., presence of active GVHD of the gastrointestinal tract as manifested by rising liver function tests (LFTs) prior to initiation of study treatment
✕. Uncontrolled infection
✕. Major surgery within the past 2 months
✕. The use of another investigational drug within the previous 30 days.
What they're measuring
1
The number of participants that do not require a reduction in drug dose for more than 21 days due to adverse events.