Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
ConditionIdiopathic Pulmonary Fibrosis (IPF)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSunshine Lake Pharma Co., Ltd.
About this trial
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)
Eligibility criteria
Qualifiers
Voluntarily participate in this clinical study and sign the informed consent form before the study begins;
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;
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;
The ratio of forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) at the screening period is ≥ 0.7;
Disqualifiers
The researchers believe that the subjects experienced significant deterioration of IPF within the first three months of the randomization period.
Other known causes of interstitial lung disease, such as exposure to the home or occupational environment, connective tissue diseases, drug toxicity, etc.
Abnormalities in the lungs or chest that are clinically significant and judged by the researchers to potentially affect the trial results.
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).
Trial design
Treatments tested in this trial
- HEC585
- Placebo
- Pirfenidone
Treatment groups
472 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov