A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease

Recruiting now · Phase 4 · Has a placebo group

Conditions studied: Interstitial Lung Disease (ILD), Connective Tissue Disease-associated Interstitial Lung Disease

In brief

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.

Key facts

Study ID: NCT07319598
Run by: Peking University Third Hospital
People needed: 100
Starts: 2023-11-02
Expected to finish: 2027-01-01
Last updated by the study team: 2026-01-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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
FVC ≥40% 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 may not qualify if…

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)

Where it is running

Peking University Third Hospital — Beijing, China (enrolling)

Full record on ClinicalTrials.gov

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