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Interstitial Lung Disease (ILD)Phase 4NCT07319598

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

A Phase 4 study testing Tetrandrine Tablets in people with Interstitial Lung Disease (ILD) and Connective Tissue Disease-associated Interstitial Lung Disease, run by Peking University Third Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Tetrandrine Tablets
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteChina
Study dates
2 Nov 2023to 1 Jan 2027
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting

  • Peking University Third Hospital

    Beijing

    Zhang Jing, +86-156119633822, jiaqi@bjmu.edu.cn

    Recruiting

Other trials in China

About this study

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

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.

Read the 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.

Being tested
Tetrandrine Tablets, Placebo
Keywords
Tetrandrine, Connective Tissue Disease, Interstitial Lung Disease, Pulmonary Function, Inflammatory Markers
Medical subject headings
Lung Diseases, Interstitial, Connective Tissue Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tetrandrine TabletsDrug

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

  • PlaceboDrug

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

Study groups in NCT07319598
Study groupRoleWhat they receive
Tetrandrine GroupExperimentalParticipants receive tetrandrine tablets (60 mg, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).
Receives: Drug: Tetrandrine Tablets
Placebo GroupPlacebo comparatorParticipants receive placebo tablets (mimicking tetrandrine, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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）

    Measured: Baseline to 24 weeks

Secondary outcomes (14)

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

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline to 24 weeks

  5. Change in Semi-Quantitative High-Resolution Computed Tomography (HRCT) Score

    Semi-quantitative scoring of HRCT patterns (reticulation, ground-glass opacity, patchy/consolidation, honeycombing) across 6 predefined lung layers. Each pattern scored 0 (absent) to 4 (>75% involvement); total score summed (maximum 96). Higher scores indicate worse outcome (greater lung involvement). Units: Score (0-96)

    Measured: Baseline to 24 weeks

  6. Change in Total Lung Capacity (TLC)

    TLC measured via body plethysmography (ATS/ERS standards) at central facility. Units: Absolute value（L）

    Measured: Baseline to 24 weeks

  7. Change in Vital Capacity (VC)

    VC measured via spirometry (ATS/ERS standards) at central facility. Units: Absolute value（L）

    Measured: Baseline to 24 weeks

  8. Change in Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)

    Single-breath DLCO (hemoglobin-corrected) measured via ATS/ERS standards at central facility.

    Measured: Units: Absolute value（L）

  9. Change in Arterial Partial Pressure of Oxygen (PaO2)

    PaO2 from arterial blood gas (at rest, room air). Units: mmHg

    Measured: Baseline to 24 weeks

  10. Change in St. George's Respiratory Questionnaire (SGRQ) Total Score

    Change in total score from Chinese-validated SGRQ (self-administered, 3-month recall), assessing respiratory health-related quality of life across Symptoms, Activity, and Impacts domains (weighted). Scores range from 0 (no impairment/best quality of life) to 100 (maximum impairment/worst quality of life). Higher scores indicate worse outcome. Units: Score (0-100)

    Measured: Baseline to 24 weeks

  11. Number of Participants with Treatment-Related Adverse Events as Assessed by CTCAE v5.0

    Incidence of treatment-related adverse events (any untoward event post-randomization), graded by CTCAE v5.0 (coded via MedDRA). Includes abnormalities in hematology, chemistry, urinalysis, liver/kidney function. Units: Number of cases

    Measured: Baseline to 24 weeks

  12. Number of Participants with Treatment-Emergent Serious Adverse Events

    Incidence of serious adverse events as assessed by CTCAE v5.0. Units: Number of cases

    Measured: Baseline to 24 weeks

  13. Number of Participants with Clinically Significant Abnormalities in Electrocardiogram (ECG)

    Incidence of clinically significant ECG abnormalities (e.g., QTc prolongation) from 12-lead ECGs. Units: Number of cases

    Measured: Baseline to 24 weeks

  14. Number of Participants with All-Cause Mortality

    Number and percentage of participants who died from any cause during the study period (all-cause mortality), ascertained via follow-up and vital status checks. Units: Number of cases

    Measured: Baseline to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2026
  2. Study start2 Nov 2023
  3. Primary completion15 Oct 2026 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07319598
Sponsor's protocol ID
V1.5/2024.11.08
Status last verified
Aug 2025
First submitted
27 Aug 2025
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tetrandrine Tablets in people with Interstitial Lung Disease (ILD) and Connective Tissue Disease-associated Interstitial Lung Disease, run by Peking University Third Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Forced Vital Capacity (FVC) (time frame: Baseline to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07319598.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.

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