Actively Recruiting
A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease
Led by Peking University Third Hospital · Updated on 2026-01-06
100
Participants Needed
1
Research Sites
165 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study evaluates the efficacy and safety of tetrandrine tablets (60 mg, three times daily) compared to placebo in adult patients with connective tissue disease-related interstitial lung disease. Patients receive standard treatment (glucocorticoids and immunosuppressants) alongside the study drug or placebo for 24 weeks. The study measures changes in lung function, inflammatory markers, lung imaging, quality of life, and safety outcomes.
CONDITIONS
Official Title
A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients who voluntarily participate and sign the informed consent form
- Male or female patients aged 18-80 years (inclusive)
- Patients meeting the diagnostic criteria for connective tissue disease-related interstitial lung disease per the 2018 Chinese Expert Consensus at screening
- Forced vital capacity (FVC) 240% of predicted value at screening
- Fertile male or female patients must agree to use effective contraception from signing informed consent until 3 months after the last study drug dose (Exemptions: postmenopausal women >50 years with amenorrhea for >1 year, or surgically sterilized women)
- Patients on stable doses of prednisone (20 mg/day or equivalent) or immunosuppressants for at least 4 weeks prior to study entry, with dose adjustments not exceeding this during the double-blind period
You will not qualify if you...
- Treatment with tetrandrine or other antifibrotic drugs within 1 month before screening
- Diabetes with fasting blood glucose greater than 11.1 mmol per L
- Resting arterial oxygen partial pressure less than 50 mmHg
- Active peptic ulcers or bleeding disorders
- Tumors with expected survival less than 1 year
- Active pulmonary tuberculosis
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 5 times the upper limit of normal (ULN) or higher, or ALT or AST 3 times ULN or higher with total bilirubin 2 times ULN or higher
- Creatinine clearance less than 30 mL per min (per Cockcroft-Gault formula) or patients receiving dialysis
- Known allergy to tetrandrine or its excipients
- Severe psychological, mental, cognitive, or intellectual impairments that may affect compliance
- Pregnant or breastfeeding women, or those planning pregnancy within 3 months after the last study drug dose
- Participation in another clinical trial within 3 months before screening
- Patients deemed unsuitable for the study by the investigator
- Clinically significant environmental exposure history that may cause pulmonary fibrosis (e.g., amiodarone, asbestos, beryllium, radiation)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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