Idiopathic Pulmonary Fibrosis
Conditions
Interventions
Sponsors
Fujian Medical University Union Hospital
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. IPF patients must be =40 and =75 years old (inclusive) at the time of signing the informed consent form; 2. Participants must have been diagnosed with IPF prior to screening according to the ATS/ERS/JRS/ALAT International Diagnostic Guidelines (2022) and/or the Chinese Expert Consensus on the Diagnosis and Management of Idiopathic Pulmonary Fibrosis (2016), based on chest HRCT imaging with or without biopsy.
Exclusion criteria
Exclusion criteria: 1. Patients with interstitial lung disease (ILD) of other known etiologies (e.g., connective tissue disease-associated ILD, drug-induced ILD, pneumoconiosis, hypersensitivity pneumonitis, or radiation pneumonitis); 2. Those who experienced major trauma or underwent major surgery within 12 months prior to screening (as assessed by the investigator); 3.Concurrent severe medical conditions deemed by the investigator likely to affect trial participation, including but not limited to: life-threatening comorbidities, history of autoimmune diseases, etc.; 4. Individuals testing positive for hepatitis B surface antigen (HBsAg), or those with negative HBsAg but positive hepatitis B core antibody (HBcAb) with detectable HBV-DNA; positive anti-hepatitis C virus (anti-HCV) antibody with detectable HCV-RNA; positive HIV antigen/antibody; or positive Treponema pallidum antibody; 5. Patients who received systemic corticosteroids* or other immunosuppressants** within 3 months prior to screening; *Note: Systemic corticosteroids include but are not limited to hydrocortisone, prednisone, nilestriol, methylprednisolone, fludrocortisone. Short-term systemic corticosteroid use (<=3 days for short-acting agents or <=2 days for long-acting agents) is excluded. **Other immunosuppressants include but are not limited to cyclophosphamide, azathioprine, methotrexate, cyclosporine, tacrolimus, mycophenolate mofetil, TNF-a antagonists, JAK inhibitors, colchicine, etc. Systemic treatments exclude topical applications (e.g., ocular, nasal, dermal, or inhaled). 6. Patients with concurrent malignancies or a history of other malignancies within 5 years prior to screening (except cured basal cell or squamous cell skin carcinoma, or cervical carcinoma in situ).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Inflammatory Factors; | — |
Countries
China
Contacts
Public ContactLimin Chen
Fujian Medical University Union Hospital
Outcome results
None listed