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Nintedanib in BOS Following HSCT
NCT03805477Phase 2
Key facts
- Status
- Completed
- Start
- Mar 2019
- Primary completion
- Jul 2026
- Countries
- 2
- Sponsor
- University Hospital Basel
- Modality
- Fragment-Derived Small Molecules, Allosteric Modulators, Orthosteric Ligands
- Drugs
- nintedanib
- Conditions
- Bronchiolitis Obliterans Syndrome (BOS)
01
Overview
Phase 2, open-label, single-arm trial of nintedanib in Bronchiolitis Obliterans Syndrome (BOS), sponsored by University Hospital Basel. Primary endpoint: Adverse event rate leading to interruption/discontinuation of study treatment at 12 months. Started Mar 2019; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Nintedanib
Nintedanib 150 mg Kps bid (oral) + basic immunosuppressive treatment
03
Who it enrols
Patients with bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic cell transplantation within 5 years, meeting NIH criteria for BOS, without acute pulmonary infection, chronic oxygen therapy, or hematologic relapse.
04
Endpoints
Primary
Adverse event rate leading to interruption/discontinuation of study treatment
Secondary
Change of the percent of predicted forced expiratory volume in 1 second
Change in forced vital capacity
Change in total lung capacity
Change in diffusion capacity of the lung for carbon monoxide
Change in exhaled nitric oxide
Nitrogen (N2)-washout
Changes in 6 minutes walking distance
Cumulative steroid doses
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