A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tetrandrine Tablets, Placebo.
- Who it may be relevant to
- Registry conditions: Interstitial Lung Disease (ILD), Connective Tissue Disease-associated Interstitial Lung Disease. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Detailed description
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.
Interventions
- Drug Tetrandrine Tablets
60 mg (3 tablets, 20 mg each), orally three times daily (TID) for 24 weeks, with glucocorticoids and immunosuppressants - Drug Placebo
Placebo tablets mimicking tetrandrine, 3 tablets TID, orally for 24 weeks, with glucocorticoids and immunosuppressants
Primary outcome measures
- Change in Forced Vital Capacity (FVC) [Time frame: Baseline to 24 weeks]
Secondary outcome measures (12)
- Change in Serum Transforming Growth Factor Beta 1 (TGF-β1) Level [Time frame: Baseline to 24 weeks]
- Change in Serum Krebs von den Lungen-6 (KL6) Level [Time frame: Baseline to 24 weeks]
- Change in Serum Tumor Necrosis Factor Alpha (TNF-α) Level [Time frame: Baseline to 24 weeks]
- Change in Serum Interleukin-6 (IL-6) Level [Time frame: Baseline to 24 weeks]
- Change in Semi-Quantitative High-Resolution Computed Tomography (HRCT) Score [Time frame: Baseline to 24 weeks]
- Change in Total Lung Capacity (TLC) [Time frame: Baseline to 24 weeks]
- Change in Vital Capacity (VC) [Time frame: Baseline to 24 weeks]
- Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO) [Time frame: Units: Absolute value（L）]
- Change in Arterial Partial Pressure of Oxygen (PaO2) [Time frame: Baseline to 24 weeks]
- Change in St. George's Respiratory Questionnaire (SGRQ) Total Score [Time frame: Baseline to 24 weeks]
- Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0 [Time frame: Baseline to 24 weeks]
- Number of Participants with Treatment-Emergent Serious Adverse Events [Time frame: Baseline to 24 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Peking University Third Hospital — Beijing
Identifiers
NCT: NCT07319598 · V1.5/2024.11.08