Tests immunoglobulin infusions for sudden worsening of pulmonary fibrosis
Tests intravenous immunoglobulin added to usual care in adults hospitalized with pulmonary fibrosis flare-ups.
Plain-language title generated from the registry record
Registry title: Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
Key facts
- Where
- Pátrai, GreeceSee the site
- Phase
- Phase 3
Where in Greece
- Department of Respiratory Medicine, University Hospital of PatrasPátrai, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Argyrios Tzouvelekis
- Trial code
- NCT07299695
- Record updated
- 16 March 2026
- Original description
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.Read full original descriptionShow less
A Prospective, Multicenter, Randomized, Open-Label Clinical Trial Evaluating the Efficacy of Intravenous Immunoglobulin in Patients Hospitalized for Acute Exacerbations of Idiopathic Pulmonary Fibrosis.
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.
Inclusion: 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; The criteria of IPF-AE are as follows:; Previous or concurrent diagnosis of IPF; Acute worsening or development of dyspnoea typically < 1 month duration; Computed tomography with new bilateral ground-glass opacity and/or consolidation superimposed on a background pattern consistent with usual interstitial pneumonia pattern; Deterioration not fully explained by cardiac failure or fluid overload Patients who fail to meet all 4 criteria due to missing computed tomography should be considered as having "suspected Acute Exacerbation"; If the diagnosis of IPF is not previously established, this criterion can be met by the presence of radiologic and/or histopathologic changes consistent with usual interstitial pneumonia pattern on the current evaluation; If no previous computed tomography is available, the qualifier "new" can be dropped from the third AE-IPF criterion; Patient able to understand and sign a written informed consent form. In case of incapacity of the patient, the written informed consent form will be signed by the patients' legally authorized representative.
Exclusion: Patients with active malignancy or currently receiving cancer treatment, except for basal cell or squamous cell skin cancer or low-risk prostate cancer (T1 or T2a stage with PSA <10 ng/dL). These criteria are aligned with current guidelines; Patients that have received treatment for >14 days within the preceding month with >20mg daily prednisone (or equivalent) or any treatment during the last month with immunosuppressants (e.g., cyclophosphamide, mycophenolate etc.) according to already published therapeutic protocols or > 1 mg/kg/d from more than 7 days in the last 15 days; 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; Patients participating to another interventional clinical trial; Patients with documented pregnancy or lactation; Patients under tutorship or curatorship; Patients deprived of liberty or under court protection; Patients who refuse to participate or decline to provide written informed consent.