A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease
A Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Tetrandrine Tablets in Treating Interstitial Lung Disease Related to Connective Tissue Disease
Peking University Third Hospital
100 participants
Nov 2, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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
Exclusion Criteria14
- 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)
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Interventions
60 mg (3 tablets, 20 mg each), orally three times daily (TID) for 24 weeks, with glucocorticoids and immunosuppressants
Placebo tablets mimicking tetrandrine, 3 tablets TID, orally for 24 weeks, with glucocorticoids and immunosuppressants
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07319598