IVIG for sudden severe flare-ups of idiopathic pulmonary fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, randomized, phase 3 study that will assign adults hospitalized with definite or suspected acute exacerbations of IPF to receive IVIG plus usual care or usual care alone. IVIG will be given as an adjunct to standard management, which typically includes pulse corticosteroids, broad-spectrum antibiotics, prophylactic anticoagulation, and oxygen. The trial is multicenter in design and focuses on clinically relevant outcomes such as survival and gas exchange during the acute hospitalization. Enrollment targets adults meeting international criteria for AE-IPF.

Why it matters

Who can join: the full rules

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.

Where it's running

• Department of Respiratory Medicine, University Hospital of Patras
  Pátrai, Greece Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• New IPF drug ORJ-001 tested in adults with IPF

  A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.

  Recruiting at 2 sites Phase 2 Oorja Bio, Inc. · Doral, Florida and 1 other locations · NCT07869147

• Nalbuphine ER for IPF-related chronic cough

  This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.

  Recruiting at 4 sites Phase 3 Trevi Therapeutics · Wilmington, Delaware and 3 other locations · NCT07868419

• Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients

  This observational study tests how fast patients with IPF or PPF can inhale through dry powder inhalers with different resistances.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07820254

• Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs

  This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• Rentosertib by mouth for people with idiopathic pulmonary fibrosis

  This is a randomized, placebo-controlled test to see if Rentosertib helps adults with idiopathic pulmonary fibrosis when taken as a pill.

  Recruiting at 12 sites Phase 3 InSilico Medicine Hong Kong Limited · Hefei, Anhui and 46 other locations · NCT07687459

• Inhaled nintedanib powder for IPF in adults

  This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.

  Recruiting Phase 2 Mannkind Corporation · Windsor, Ontario · NCT07679893

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.