NCT07319598 A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease
| NCT ID | NCT07319598 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Peking University Third Hospital |
| Condition | Interstitial Lung Disease (ILD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2026-10-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 100 participants in total. It began in 2023-11-02 with a primary completion date of 2026-10-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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)
Frequently Asked Questions
Who can join the NCT07319598 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Interstitial Lung Disease (ILD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07319598 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07319598 currently recruiting?
Yes, NCT07319598 is actively recruiting participants. Visit ClinicalTrials.gov or contact Peking University Third Hospital to inquire about joining.
Where is the NCT07319598 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07319598 clinical trial?
NCT07319598 is sponsored by Peking University Third Hospital. The trial plans to enroll 100 participants.