Stable idiopathic pulmonary fibrosis
Conditions
Interventions
Low-dose group:Mito-WT1
Medium dose group:Mito-WT1
High dose group:Mito-WT1
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.Aged 40-80 years; 2.Study participants have signed informed consent forms, understand the purpose, procedures, and content of the study, and willingly participate in the study; 3.Diagnosed with IPF according to the ATS/ERS/JRS/ALAT clinical practice guidelines for idiopathic pulmonary fibrosis (2022) with HRCT diagnosis of UIP pattern/possible UIP pattern (confirmed after review by an independent imaging review panel) with or without pathological UIP pattern/possible UIP pattern; for HRCT diagnosed indefinite for UIP, pathology must be UIP pattern/possible UIP pattern (pathology refers to cryobiopsy or surgical/thoracoscopic lung biopsy); 4.Study participants receiving a background regimen of pirfenidone or nintedanib, if treated with a stable antifibrotic regimen for over 8 weeks before Visit 1, may be included in the study; 5.IPF patients who have had pulmonary function test results on at least two occasions in the past two years; 6.Adequate organ function, within 7 days prior to starting treatment, with complete blood count, liver and kidney function, coagulation laboratory tests meeting the following criteria: white blood cells (WBC) >= 3.5×10^9/L, platelets (PLT) >= 80×10^9/L, absolute neutrophil count (ANC) >= 1.5×10^9/L, hemoglobin (HGB) >= 90g/L, aspartate aminotransferase (AST) <2.5× upper limit of normal (ULN) (for those with liver metastasis <5×ULN), alanine aminotransferase (ALT) <2.5×ULN (for those with liver metastasis <5×ULN), total bilirubin (TIBC) <1.5×ULN, serum creatinine (CR) <1.0×ULN, prothrombin time, activated partial thromboplastin time, plasma fibrinogen, and thrombin time within normal ranges.
Exclusion criteria
Exclusion criteria: 1.Patients with an acute exacerbation of IPF within 4 weeks prior to screening or during the screening period; 2.Interstitial lung disease (ILD) other than IPF, including but not limited to: any other type of idiopathic interstitial pneumonia; lung diseases associated with exposure to fibrogenic agents or other environmental toxins or drugs; other types of occupational lung diseases; granulomatous lung disease; pulmonary vasculitis; systemic diseases, including vasculitis, infectious diseases (i.e., tuberculosis), and connective tissue diseases. If the diagnosis is unclear, serological tests and/or multi-disciplinary expert panel reviews should be conducted to confirm the diagnosis of IPF or other types of ILD.; 3.Active viral, bacterial, or other pathogenic infections that cannot be controlled with appropriate anti-infective treatment; 4.With a history of malignant tumors (excluding cancers that have been cured or in remission for >=5 years, basal or squamous cell skin cancer that has been radically excised, in situ cervical cancer, and excised colonic polyps).; 5.Seropositive for HIV, syphilis, active hepatitis B, or hepatitis C infection; 6.With psychiatric disorders or other conditions that prevent compliance with study treatment and monitoring requirements.; 7.Allergy to any component in immunomodulatory agents; 8.Organ transplant recipients; 9.Poor compliance; 10.Pregnant or lactating women. 11. There are nasal diseases such as abnormal nasal structure that affect the absorption of drugs administered through the nose.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pulmonary function test;HRCT;Frequency of acute exacerbation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom assessment;Vital signs and physical examination;Exercise tolerance test;Laboratory examination; | — |
Countries
China
Contacts
Public ContactTing Yang; Xiawei Wei
West China Hospital, Sichuan University
Outcome results
None listed