Interventional Recruiting Phase 3
NCT07299695 on ClinicalTrials.gov
Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Official title: A Prospective, Multicenter, Randomized, Open-Label Clinical Trial Evaluating the Efficacy of Intravenous Immunoglobulin in Patients Hospitalized for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.
- Sponsor: Argyrios Tzouvelekis
- Enrollment: 196 (Estimated)
- Study start: 2026-01-25 (Actual)
- Primary completion: 2028-06-01 (Estimated)
- Study completion: 2028-12-01 (Estimated)
- Allocation: Randomized
- InterventionModel: Parallel
- Masking: None
- PrimaryPurpose: Treatment
Brief Summary
Acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF) are sudden and severe worsening episodes that can be life-threatening. Currently, no treatment has been proven to clearly improve outcomes during these events. Inflammation and immune system imbalance are thought to play an important role in causing AE-IPF. Early clinical experience suggests that intravenous immunoglobulin (IVIG) can be beneficial for patients suffering from AE-IPF. This clinical trial aims to determine whether adding IVIG to usual treatment can improve outcomes for patients hospitalized with AE-IPF.
Conditions
- Idiopathic Pulmonary Fibrosis
- Acute Exacerbation of Idiopathic Pulmonary Fibrosis
Intervention / Treatment
- Drug: Intravenous immunoglobulin (IVIG)
- Drug: Usual treatment
Primary Outcome Measures
-
All-cause in-hospital mortality or intubation
(From date of randomization until the outcome mesure - the date of death from any cause or the date of endotracheal intubation, whichever comes first - assessed up to 4 weeks during hospitalisation.)
This outcome corresponds to the all-cause mortality or intubation rate throughout hospitalisation.
Countries
Greece
Locations and Investigators
- Department of Respiratory Medicine, University Hospital of Patras, Pátrai, Greece (Recruiting)