NCT07299695 Intravenous Immunoglobulin for the Treatment of Acute Exacerbations of Idiopathic Pulmonary Fibrosis
| NCT ID | NCT07299695 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Argyrios Tzouvelekis |
| Condition | Idiopathic Pulmonary Fibrosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 196 participants |
| Start Date | 2026-01-25 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 196 participants in total. It began in 2026-01-25 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Patients ≥ 18 years of age 2. Patients with IPF diagnosis that fulfils ATS/ERS Consensus Criteria. 3. 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". A) 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. B) If no previous computed tomography is available, the qualifier "new" can be dropped from the third AE-IPF criterion. 4. 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 Criteria: 1. Patients with acute worsening due to uncontrolled heart failure or pulmonary embolism. 2. Patients with known hypersensitivity to corticosteroids, IVIG or any component of the study treatment. 3. Patients with known IgA deficiency (IgA level \<7 mg/dL)- to preclude IVIG reactions. 4. Patients without a definite diagnosis of IPF or AE-IPF based on clinical, radiological, laboratory evaluation, and multidisciplinary discussion. 5. 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. 6. 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. 7. Patients participating to another interventional clinical trial. 8. Patients with documented pregnancy or lactation. 9. Patients under tutorship or curatorship. 10. Patients deprived of liberty or under court protection. 11. Patients who refuse to participate or decline to provide written informed consent.
Frequently Asked Questions
Who can join the NCT07299695 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Idiopathic Pulmonary Fibrosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07299695 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 196 participants.
Is NCT07299695 currently recruiting?
Yes, NCT07299695 is actively recruiting participants. Visit ClinicalTrials.gov or contact Argyrios Tzouvelekis to inquire about joining.
Where is the NCT07299695 trial being conducted?
This trial is being conducted at Pátrai, Greece.
Who is sponsoring the NCT07299695 clinical trial?
NCT07299695 is sponsored by Argyrios Tzouvelekis. The trial plans to enroll 196 participants.