At a glance
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Study of Therapeutic Plasma Exchange, Rituximab and Intravenous Immunoglobulin for Acute Exacerbations of Idiopathic Pulmonary Fibrosis (STRIVE-IPF)
In Brief
A Phase 2 clinical trial evaluating Autoantibody Reductive Therapy and Treatment as Usual (TAU) for Idiopathic Pulmonary Fibrosis, Acute Fatal Form. Completed, enrolled 82 participants across 7 sites.
Detailed Summary
Acute exacerbations (AE) are a dreaded manifestation of idiopathic pulmonary fibrosis (IPF) that presents with rapidly worsening respiratory function over days to weeks. AE account for about 1/2 the deaths in IPF patients, and are refractory to all medical therapies attempted to date. Considerable preliminary data shows pathological B-cell abnormalities and autoantibodies are present in AE-IPF and associated with disease severity. The experimental therapy here (therapeutic plasma exchange plus rituximab plus intravenous immunoglobulin) is mechanistically targeted to ameliorate autoantibody-mediated pulmonary injury. Anecdotal pilot studies indicate these treatments have significant benefit for a disease syndrome that has, until now, been almost invariably inexorable. This clinical trial has the potential to profoundly affect current paradigms and treatment approaches to patients with AE-IPF.
Study Details
Timeline
Interventions
TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
Antibiotics and steroids