Actively Recruiting
Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Led by Argyrios Tzouvelekis · Updated on 2026-03-16
196
Participants Needed
1
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients aged 18 years or older
- Diagnosis of idiopathic pulmonary fibrosis (IPF) according to ATS/ERS Consensus Criteria
- Hospitalized with definite or suspected acute exacerbation of IPF based on international criteria, including acute worsening of breathlessness less than 1 month, new bilateral ground-glass opacity or consolidation on CT scan, and no explanation by heart failure or fluid overload
- Able to understand and sign informed consent or have a legally authorized representative sign it
You will not qualify if you...
- Acute worsening due to uncontrolled heart failure or pulmonary embolism
- Known allergy or hypersensitivity to corticosteroids, IVIG, or study treatment components
- Known IgA deficiency (IgA level less than 7 mg/dL)
- No definite diagnosis of IPF or acute exacerbation of IPF confirmed by clinical, radiological, laboratory, and multidisciplinary evaluation
- Active cancer or current cancer treatment except for basal or squamous cell skin cancer or low-risk prostate cancer (T1 or T2a stage with PSA less than 10 ng/dL)
- Received more than 14 days of prednisone over 20 mg daily or immunosuppressants within the last month, or more than 7 days of prednisolone over 1 mg/kg/day in the last 15 days
- Participation in another interventional clinical trial
- Pregnancy or breastfeeding
- Under legal tutorship or curatorship
- Deprived of liberty or under court protection
- Refusal or inability to provide written informed consent
AI-Screening
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Trial Site Locations
Total: 1 location
1
Department of Respiratory Medicine, University Hospital of Patras
Pátrai, Greece, 26504
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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