Phase 4 Interstitial Lung Disease Trial, Recruiting NCT07319598 Sponsor: Peking University Third Hospital Condition: Interstitial Lung Disease
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Phase 4 Interstitial Lung Disease Trial, Recruiting

NCT07319598
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to take part and agree to sign a consent form
  • You are between 18 and 80 years old (inclusive)
  • You have been diagnosed with a lung disease called connective tissue disease-related interstitial lung disease, based on specific Chinese medical guidelines from 2018 (confirm with trial site)
  • Your lung capacity (a measure called FVC) is at least 40% of the expected normal value for someone your age and size
  • If you are able to have children, you must agree to use reliable contraception from signing the consent form until 3 months after your last dose of the study drug (this does not apply to women over 50 who have not had a period for more than one year, or women who have had a sterilisation procedure)
  • You have been taking a stable dose of steroid tablets (such as prednisone, no more than 20 mg per day) or immune-suppressing medicines for at least 4 weeks before joining, and your dose has not been significantly changed

Who may not be able to join:

  • You have taken a drug called tetrandrine or other anti-scarring lung medicines within the past month
  • You have diabetes and your fasting blood sugar level is very high (above 11.1 mmol per litre)
  • Your blood oxygen levels at rest are very low (confirm with trial site)
  • You have an active stomach ulcer or a condition that causes serious bleeding problems
  • You have a cancer where doctors expect you to live less than one year
  • You currently have active tuberculosis (TB) in your lungs
  • Your liver test results are significantly above normal levels (confirm with trial site for specific values)
  • Your kidneys are working at a very low level, or you are currently on dialysis
  • You have a known allergy to tetrandrine or any of its ingredients
  • You have serious psychological, mental, or cognitive difficulties that might affect your ability to follow the study instructions
  • You are pregnant, breastfeeding, or planning to become pregnant within 3 months after your last dose of the study drug
  • You have taken part in another clinical trial within the past 3 months
  • The trial doctor does not think the study is right for you for any other reason
  • You have had significant exposure to certain substances or treatments that can cause lung scarring, such as asbestos, radiation, or certain medications like amiodarone (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 26 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Peking University Third Hospital
Registry
ClinicalTrials.gov
Start date
2 November 2023
Est. completion
15 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change in Forced Vital Capacity (FVC)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov