Acute exacerbation of idiopathic pulmonary fibrosis
Conditions
Interventions
Experimental group:Subcutaneous injection of Firsekibart
Sentry Team:Subcutaneous injection of Firsekibart
Sponsors
Shanghai Pulmonary Hospital
Eligibility
Sex/Gender
All
Age
40 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age >= 40 years; 2.Based on the comprehensive judgment of the researchers, the past medical history conforms to the clinical diagnosis and treatment standards outlined in the 2022 ATS/ERS/JRS/ALAT guidelines, thus the diagnosis of idiopathic pulmonary fibrosis (IPF) can be confirmed; 3.Subjects diagnosed with acute exacerbation of idiopathic pulmonary fibrosis (AE-IPF) by researchers, who have experienced worsening or new onset of dyspnea or hypoxemia within the last 30 days, and meet all of the following criteria (1) to (3) during the course of the disease: (1) Unexplained sudden onset or worsening of dyspnea within 1 month (or 30 days); (2) Chest high-resolution computed tomography (HRCT) with local review showing ground-glass opacity and/or consolidation on the basis of a reticular or honeycombing usual interstitial pneumonia (UIP) pattern; (3) No significant pneumothorax, malignancy, pulmonary embolism, or left heart failure; 4.Possess the ability to provide informed consent and are willing to adhere to the research requirements;
Exclusion criteria
Exclusion criteria: 1.Based on clinical evaluation, there are other or alternative causes leading to respiratory insufficiency, including congestive heart failure, severe infection, thromboembolism, etc; 2.Acute deterioration due to thoracic surgery (including thoracoscopic lung biopsy); 3.Receive mechanical ventilation through endotracheal intubation; 4.IPF patients who have known acute exacerbation in the past 6 months (subject to medical records); 5.Subjects who are HIV-positive, HBsAg-positive, HCVAb-positive, specific treponema antibody-positive, or have syphilis infection are excluded. (1) HBV-positive is defined as HBsAg-positive or HBcAb-positive + HBV DNA-positive. Subjects with HBcAb-positive + HBV DNA-negative are also allowed to be included. (2) HCV-positive is defined as HCV antibody-positive + HCV RNA-positive. Subjects with HCV antibody-positive + HCV RNA-negative are also allowed to be included. (3) HIV-positive is defined as HIV antibody-positive. 6.Excluding patients with tuberculosis infection, including tuberculosis (TB) or latent tuberculosis infection (meeting one of the following criteria): (1) active TB or symptoms of active TB at screening; (2) active TB indicated by physical examination; (3) positive gamma interferon release test within 4 weeks before or at screening; (4) active TB signs indicated by imaging examination within 3 months before screening; 7.The presence of hyperosmolarity or diabetic ketoacidosis indicates uncontrolled diabetes, or the presence of uncontrolled hypertension (systolic blood pressure >160 mmHg and diastolic blood pressure >100 mmHg), which are contraindications to the use of corticosteroids; 8.Coagulopathy is defined as an international normalized ratio (INR) >1.6, a partial thromboplastin time (PTT) >2 times the control value, a fibrinogen level <100 mg/dL, or a platelet count <50K/µL, unless these abnormalities can be safely corrected; 9.Active malignancy or undergoing treatment for malignancy (excluding basal cell carcinoma or squamous cell skin cancer, as well as low-risk prostate cancer. Low-risk prostate cancer is defined as T1 or T2a stage, with prostate-specific antigen (PSA) less than 10 ng/dl). Experimental treatments are known not to promote cancer progression, and these criteria are in accordance with current guidelines; 10.Previous treatment with any of the following medications: (1) Antifibrotic drugs: Patients who have received background treatment with antifibrotic drugs (pirfenidone and nintedanib, hereinafter referred to as SOC) are allowed to continue using SOC during the trial, with minimal dosage adjustments; patients who have not used SOC before enrollment must promise not to use SOC during the study process when providing informed consent. (2) Previous treatment with IL-1ß monoclonal antibody or other drugs targeting the same target (including but not limited to anakinra, canakinumab, linaclotide, etc.) before enrollment; 11.Females who are capable of bearing children do not agree to contraception or abstinence, or test positive for pregnancy (urine or blood). Idiopathic pulmonary fibrosis (IPF) is a disease that primarily affects older adults and is more common in males, so this situation is rare; 12.Participate in other interventional clinical studies at the same time. If the subject has previously participated in other interventional clinical studies, they must wait until the completion of those previous studies before being considered for participation in this study; 13.Subje
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Survival rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with effective hormone reduction and proportion of successful subjects with effective hormone reduction;The safety evaluation indicators include: vital signs, physical examination, laboratory examination, 12 lead electrocardiogram, adverse events (AE), etc; | — |
Countries
China
Contacts
Public ContactChang Chen
Shanghai Pulmonary Hospital
Outcome results
None listed