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
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change in Forced Vital Capacity (FVC)
研究概览
简要总结
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.
详细描述
This multicenter, randomized, double-blind, placebo-controlled study enrolls 100 adults with connective tissue disease-related interstitial lung disease. Patients are randomized 1:1 to receive tetrandrine tablets (60 mg TID) or placebo for 24 weeks, alongside standard treatment. The primary outcome is the change in forced vital capacity (FVC) at 24 weeks. Secondary outcomes include changes in serum inflammatory markers (TGF-β1, KL6, TNF-α, IL-6), lung HRCT scores, other Lung function parameters (TLC, VC, DLCO, PaO2), St. George's Respiratory Questionnaire (SGRQ) score, safety parameters, and all-cause mortality. Visits occur at weeks 4, 8, 12, and 24 for efficacy and safety assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
Tetrandrine Group
Participants receive tetrandrine tablets (60 mg, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).
干预措施: Tetrandrine Tablets (Drug)
Placebo Group
Participants receive placebo tablets (mimicking tetrandrine, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Forced Vital Capacity (FVC)
时间窗: Baseline to 24 weeks
Change in forced vital capacity (FVC) expressed in liters (L) of predicted normal value, measured using a pulmonary function testing device in accordance with ATS/ERS standards at a central facility. Units: Absolute value（L）
次要结局
- Change in Serum Interleukin-6 (IL-6) Level(Baseline to 24 weeks)
- Change in Semi-Quantitative High-Resolution Computed Tomography (HRCT) Score(Baseline to 24 weeks)
- Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(Units: Absolute value（L）)
- Change in Serum Transforming Growth Factor Beta 1 (TGF-β1) Level(Baseline to 24 weeks)
- Change in Serum Krebs von den Lungen-6 (KL6) Level(Baseline to 24 weeks)
- Change in Serum Tumor Necrosis Factor Alpha (TNF-α) Level(Baseline to 24 weeks)
- Change in Total Lung Capacity (TLC)(Baseline to 24 weeks)
- Change in Vital Capacity (VC)(Baseline to 24 weeks)
- Change in Arterial Partial Pressure of Oxygen (PaO2)(Baseline to 24 weeks)
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0(Baseline to 24 weeks)
- Change in St. George's Respiratory Questionnaire (SGRQ) Total Score(Baseline to 24 weeks)
- Number of Participants with Treatment-Emergent Serious Adverse Events(Baseline to 24 weeks)
- Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG)(Baseline to 24 weeks)
- Number of Participants with All-Cause Mortality(Baseline to 24 weeks)