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

ConditionsInterstitial Lung Disease (ILD)Connective Tissue Disease-associated Interstitial Lung Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-80
SponsorPeking University Third Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tetrandrine Tablets

    Drug

    60 mg (3 tablets, 20 mg each), orally three times daily (TID) for 24 weeks, with glucocorticoids and immunosuppressants

  • Placebo

    Drug

    Placebo tablets mimicking tetrandrine, 3 tablets TID, orally for 24 weeks, with glucocorticoids and immunosuppressants

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Tetrandrine GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Forced Vital Capacity (FVC)

Change in forced vital capacity (FVC) expressed in liters (L) of predicted normal value, measured using a pulmonary function testing device in accordance with ATS/ERS standards at a central facility. Units: Absolute value（L）

Time frame
Baseline to 24 weeks

Secondary outcomes

1

Change in Serum Transforming Growth Factor Beta 1 (TGF-β1) Level

Serum TGF-β1 levels measured via fully automated analyzer. Units: ng/mL

Time frame
Baseline to 24 weeks
2

Change in Serum Krebs von den Lungen-6 (KL6) Level

Serum KL6 levels measured via fully automated analyzer. Units: U/mL

Time frame
Baseline to 24 weeks
3

Change in Serum Tumor Necrosis Factor Alpha (TNF-α) Level

Serum TNF-α levels measured via fully automated analyzer. Units: pg/mL

Time frame
Baseline to 24 weeks
4

Change in Serum Interleukin-6 (IL-6) Level

Serum IL-6 levels measured via fully automated analyzer. Units: pg/mL

Time frame
Baseline to 24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Third Hospital

Lead sponsor

Source ClinicalTrials.gov
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