Actively Recruiting
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
Led by Sunshine Lake Pharma Co., Ltd. · Updated on 2026-04-21
472
Participants Needed
1
Research Sites
328 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
Confirmatory Clinical Study of HEC585 Tablets in Patients With IPF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntary participation with signed informed consent before starting the study
- Age between 40 and 80 years old, any gender
- Diagnosed with IPF according to 2022 clinical practice guidelines confirmed by recent HRCT 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 at screening
- Diffusing capacity of the lungs for carbon monoxide (DLco) at least 30% of predicted normal, corrected for hemoglobin
- Agree to use effective contraception from consent signing until 30 days after last drug dose and avoid sperm/egg donation
- Willing and able to follow study protocol and attend visits as assessed by investigator
You will not qualify if you...
- Significant IPF worsening within first three months after randomization
- Interstitial lung disease due to known causes such as environmental exposure, connective tissue disease, or drug toxicity
- Significant lung or chest abnormalities affecting trial results
- Active infection needing systemic treatment within one month before randomization
- Expected lung transplant during study
- Life expectancy less than 6 months
- Cancer history within last 5 years except localized basal cell carcinoma
- Moderate to severe liver dysfunction (Child-Pugh grade B or C)
- Unstable or worsening heart disease within 6 months including unstable angina, myocardial infarction, heart failure requiring hospitalization, severe arrhythmia
- Unable to perform 6-minute walk test or lung function tests
- Allergy to study drug components or pirfenidone
- Participation in other drug trials within 4 weeks or 5 half-lives before randomization
- Pregnant or breastfeeding
- Smoking within 3 months before screening or unwillingness to remain smoke-free
- Excessive alcohol use or drug abuse within 6 months before screening
- Personal or family history of long QT syndrome
- Abnormal liver function or impaired kidney function at screening
- Positive HIV, syphilis, uncontrolled hepatitis B or C infection
- Prolonged QT interval at screening
- Previous use of isoniazid hydrochloride
- Use of certain immunosuppressants, pirfenidone, prednisone >15 mg/day, or drugs affecting CYP enzymes within 4 weeks before randomization
AI-Screening
AI-Powered Screening
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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.)
CONTACT
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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