Actively Recruiting
Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
Led by Beijing Continent Pharmaceutical Co, Ltd. · Updated on 2025-11-24
272
Participants Needed
1
Research Sites
225 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a randomized, double-blind, placebo-controlled, multicenter clinical study. The main purpose of this study was to confirm the efficacy and safety of pirfenidone capsules in the treatment of pneumoconiosis.
CONDITIONS
Official Title
Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old, any gender
- Diagnosed with silicosis or coal worker's pneumoconiosis according to GBZ 70-2015 standards
- Forced vital capacity (FVC) at screening between 40% and less than 80% of predicted value
- Carbon monoxide diffusion capacity (DLCO) at screening between 30% and less than 80% of predicted value
- High-resolution CT scan shows diffuse interstitial changes in the lungs
- Able and willing to give informed consent and comply with study requirements
You will not qualify if you...
- Do not meet any inclusion criteria
- Received lung lavage therapy within 3 months or planned during the trial
- Liver enzymes ALT or AST more than 3 times upper normal limit
- Total bilirubin more than 2 times upper normal limit
- Creatinine clearance less than 30 mL/min
- Recent co-infection or high fever within 4 weeks before screening
- Having tuberculosis or lung cancer
- Severe pulmonary arterial hypertension needing certain treatments or severe right heart failure
- Severe cardiovascular disease including uncontrolled hypertension, recent myocardial infarction, or unstable angina
- Blood clotting disorders with INR > 2 or prolonged prothrombin time > 1.5 times normal
- Conditions interfering with testing or trial participation
- Dysphagia, malabsorption, or need for parenteral nutrition
- Active peptic ulcer
- Thrombotic events within past 12 months
- Use of specific immunosuppressive, cytotoxic, or other listed drugs recently
- Prior exposure to drugs causing pulmonary fibrosis or toxic substances
- Hypersensitivity to study drug components
- Life expectancy less than 2.5 years due to other conditions
- Planned major surgery during treatment
- Pregnant, breastfeeding, or unwilling to use effective contraception as required
- Alcohol or drug abuse
- Mental illness
- Participation in other drug trials within 3 months
- Investigator judgment of unfitness for trial participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Beijing China-Japan Friendship Hospital
Beijing, China
Actively Recruiting
Research Team
L
Ling Zhang, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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