Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF (NCT07082842) | Clinical Trial Compass
RecruitingPhase 3
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
China472 participantsStarted 2025-10-27
Plain-language summary
A multicenter, parallel, randomized, placebo (double-blind) and pirfenidone (open-label) controlled Phase III clinical trial to evaluate the efficacy and safety of HEC585 in patients with idiopathic pulmonary fibrosis (IPF)
Who can participate
Age range40 Years ā 80 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Voluntarily participate in this clinical study and sign the informed consent form before the study begins;
ā. When signing the informed consent form, the age should be between 40 and 80 years old (inclusive of 40 and 80), and gender is not restricted;
ā. Be diagnosed with IPF according to the diagnostic criteria of the IPF clinical practice guidelines jointly released by the American Thoracic Society, the European Respiratory Society, the Japanese Respiratory Society and the Latin American Thoracic Society in 2022 ; Chest high-resolution computed tomography (HRCT) examination (HRCT examination within 3 months before screening) or lung biopsy (if any) should be confirmed by central reading;
ā. The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ā„ 0.7;
ā. The percentage of FVC as a percentage of the normal predicted value at the screening period is ā„ 45%;
ā. The percentage of DLco (hemoglobin \[Hb\] corrected) as a percentage of the normal predicted value at the screening period is ā„ 30%;
ā. Female or male subjects with potential fertility agree and commit to taking effective contraceptive measures from the time of signing the informed consent form until 30 days after the last administration of the investigational drug; at the same time, avoid sperm/egg collection, sperm/egg donation;
ā. According to the assessment by the investigator, the subjects are willing and able to comply with the requirements of the protocol and attend the visits.
. The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period.
ā. Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc.
ā. Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results.
ā. Within one month before randomization, any active infection requiring systemic treatment (such as oral or intravenous administration) in the form of activity (including bacterial, viral, parasitic or fungal infections).
ā. Expected to undergo lung transplantation during the course of the study.
ā. Expected survival period less than 6 months.
ā. History of malignant tumors within the previous 5 years (excluding localized cancers such as basal cell carcinoma).
ā. Moderate to severe liver dysfunction (Child-Pugh classification of grade B or C).