Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorArgyrios Tzouvelekis
About this trial
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.
Eligibility criteria
Qualifiers
Patients ≥ 18 years of age
Patients with IPF diagnosis that fulfils ATS/ERS Consensus Criteria.
Patients hospitalised with a definite or suspected AE-IPF diagnosis, as defined by the international working group criteria and as ascertained by the responsible Primary Investigator.
Previous or concurrent diagnosis of IPF
Disqualifiers
Patients with acute worsening due to uncontrolled heart failure or pulmonary embolism.
Patients with known hypersensitivity to corticosteroids, IVIG or any component of the study treatment.
Patients with known IgA deficiency (IgA level <7 mg/dL)- to preclude IVIG reactions.
Patients without a definite diagnosis of IPF or AE-IPF based on clinical, radiological, laboratory evaluation, and multidisciplinary discussion.
Trial design
Treatments tested in this trial
- Intravenous immunoglobulin (IVIG)
- Usual treatment
Treatment groups
196 Participants
are divided into 2 treatment groupsSponsors and collaborators
Argyrios Tzouvelekis
Lead sponsor
University General Hospital of Patras
Sponsor institution
Source ClinicalTrials.gov