Combined PEX, Rituximab and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations
Status:
Completed
Trial end date:
2015-07-01
Target enrollment:
Participant gender:
Summary
This is an open-label Phase I/II trial to assess the feasibility and safety of combined
plasma exchange (PEX), rituximab, and conventional corticosteroid administration on the
outcome of hospitalized patients with acute IPF exacerbations. The specific aims of this
study are:
1. To assess the feasibility and safety of combined PEX, rituximab, and conventional
corticosteroid administrations for the treatment of hospitalized patients with acute IPF
exacerbations by monitoring indices of respiratory (PaO2) and cardiovascular function
during the treatment interval.
2. To assess the efficacy of combined PEX, rituximab, and conventional corticosteroid
administrations for the treatment of hospitalized patients with acute IPF exacerbations
on patient survival in comparison to historical controls. Patient survival for this
investigation will be defined using the composite outcome of 60 day survival and/or
survival to lung transplantation.
Subjects between 18 and 80 years of age who have a confirmed diagnosis of IPF, and meet all
the study requirements will be enrolled in this study. A total of 10 subjects of both genders
and all ethnic backgrounds with acute IPF exacerbations hospitalized at University of
Pittsburgh Medical Center will be enrolled in this study.