BridgeMD
New treatment option for Interstitial Lung Disease (ILD)
Official title A Study to Test Tetrandrine Tablets for Connective Tissue Disease-Related Lung Disease
ClinicalTrials.gov ID: NCT07319598
What this study is testing
What is Tetrandrine Tablets?
Tetrandrine Tablets is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for interstitial lung disease (ild).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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
See the full eligibility 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...
- 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 blinded period
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.