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New treatment option for Idiopathic Pulmonary Fibrosis
Official title Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
ClinicalTrials.gov ID: NCT07299695
What this study is testing
What is Intravenous immunoglobulin (IVIG)?
Intravenous immunoglobulin (IVIG) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for idiopathic pulmonary fibrosis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Previous or concurrent diagnosis of IPF
- Acute worsening or development of dyspnoea typically \< 1 month duration
You likely can't join if
- 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 with active malignancy or currently receiving cancer treatment, except for basal cell or squamous cell skin cancer or low-risk prostate...
- Patients that have received treatment for \>14 days within the preceding month with \>20mg daily prednisone (or equivalent) or any treatment during...
See the full eligibility criteria
- 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...
- 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". A) If the...
- 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.
- 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 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...
- 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...
- Patients participating to another treatment 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.
The study team makes the final eligibility decision.
Where it's taking place
- Pátrai, Greece
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Pátrai, Greece. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.