Actively Recruiting
A Multicenter, Parallel, Randomized, Placebo (Double-blind) and Pirfenidone (Open-label) Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of HEC585 Tablets in Patients With Idiopathic Pulmonary Fibrosis (IPF)
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-04-21
472
Participants Needed
1
Research Sites
56 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a Phase III clinical trial to study idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing difficulties. This randomized, placebo-controlled, and active comparator-controlled study evaluates the safety and effectiveness of the drug HEC585 in patients with IPF. The trial is sponsored by Sunshine Lake Pharma Co., Ltd. and aims to provide important information about treatment options for this condition. Participants will be assigned to one of three groups: one receiving HEC585 tablets once daily, another receiving a placebo tablet once daily, and a third group receiving pirfenidone three times daily as an active comparator. The study is designed with a double-blind placebo arm and an open-label pirfenidone arm to compare outcomes over the study duration. Treatments will be taken as directed, and participants will be monitored carefully throughout the trial. During the study, participants will undergo regular assessments including lung function tests like forced vital capacity (FVC), diffusion capacity of the lung for carbon monoxide (DLco), and a six-minute walk test to measure exercise tolerance. Quality of life will be evaluated using the St George's Respiratory Questionnaire (SGRQ). The primary outcome focuses on the change in FVC after 52 weeks. Researchers will also monitor safety and any clinical events during this period. The total study duration extends through the planned follow-up until February 2032.
CONDITIONS
Brief Title
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent before starting the study
- Be between 40 and 80 years old at consent, any gender
- Diagnosed with idiopathic pulmonary fibrosis (IPF) confirmed by chest HRCT within 3 months or lung biopsy
- Forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) ratio of at least 0.7 at screening
- Forced vital capacity (FVC) at least 45% of predicted normal value at screening
- Diffusion capacity of the lung for carbon monoxide (DLco), hemoglobin corrected, at least 30% of predicted at screening
- Agree to effective contraception from consent until 30 days after last dose and avoid sperm/egg donation
- Willing and able to comply with study protocol and attend visits
You will not qualify if you...
- Significant worsening of IPF within first 3 months after randomization
- Other known causes of interstitial lung disease such as environmental exposure, connective tissue disease, or drug toxicity
- Significant lung or chest abnormalities affecting study results
- Active infection requiring systemic treatment within 1 month before randomization
- Planned lung transplantation during study
- Expected survival less than 6 months
- History of malignant tumors within past 5 years except certain localized cancers
- Moderate to severe liver dysfunction (Child-Pugh grade B or C)
- History of unstable or worsening heart disease within 6 months before screening
- Unable to perform six-minute walk or lung function tests due to mental or physical reasons
- Allergy to study drugs or excipients
- Recent participation in other clinical trials with study drugs
- Pregnant or breastfeeding
- Smoking history within 3 months before screening or unwillingness to remain smoke-free
- High alcohol consumption or drug abuse history within 6 months before screening
- Family or personal history of long QT syndrome
- Conditions affecting safety, compliance, or study completion
- Abnormal liver function tests exceeding defined limits
- Reduced kidney function below specified threshold
- Positive HIV, syphilis, or uncontrolled hepatitis B or C infection
- Prolonged QT interval beyond defined limits
- Previous use of isoniazidine hydrochloride
- Recent use of certain immunosuppressants, pirfenidone, high-dose steroids, or drugs interacting with CYP enzymes within 4 weeks before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 52 weeks
Participants receive HEC585, placebo, or pirfenidone tablets daily as part of the study treatment.
Regular visits during treatment period
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
H
huaping dai Doctor of Medicine(M.D.)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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