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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Tetrandrine Tablets
  60 mg (3 tablets, 20 mg each), orally three times daily (TID) for 24 weeks, with glucocorticoids and immunosuppressants
• Препарат Placebo
  Placebo tablets mimicking tetrandrine, 3 tablets TID, orally for 24 weeks, with glucocorticoids and immunosuppressants

Первичные конечные точки

• Change in Forced Vital Capacity (FVC) [Срок оценки: Baseline to 24 weeks]

Вторичные конечные точки (12)

• Change in Serum Transforming Growth Factor Beta 1 (TGF-β1) Level [Срок оценки: Baseline to 24 weeks]
• Change in Serum Krebs von den Lungen-6 (KL6) Level [Срок оценки: Baseline to 24 weeks]
• Change in Serum Tumor Necrosis Factor Alpha (TNF-α) Level [Срок оценки: Baseline to 24 weeks]
• Change in Serum Interleukin-6 (IL-6) Level [Срок оценки: Baseline to 24 weeks]
• Change in Semi-Quantitative High-Resolution Computed Tomography (HRCT) Score [Срок оценки: Baseline to 24 weeks]
• Change in Total Lung Capacity (TLC) [Срок оценки: Baseline to 24 weeks]
• Change in Vital Capacity (VC) [Срок оценки: Baseline to 24 weeks]
• Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [Срок оценки: Units: Absolute value（L）]
• Change in Arterial Partial Pressure of Oxygen (PaO2) [Срок оценки: Baseline to 24 weeks]
• Change in St. George's Respiratory Questionnaire (SGRQ) Total Score [Срок оценки: Baseline to 24 weeks]
• Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [Срок оценки: Baseline to 24 weeks]
• Number of Participants with Treatment-Emergent Serious Adverse Events [Срок оценки: Baseline to 24 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University Third Hospital — Пекин

Идентификаторы

NCT: NCT07319598 · V1.5/2024.11.08

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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