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

NCT07319598 | Recruiting Phase 4

• 1 other identifier: V1.5/2024.11.08
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Interstitial Lung Disease (ILD); Connective Tissue Disease-associated Interstitial Lung Disease

Keywords

Tetrandrine; Connective Tissue Disease; Interstitial Lung Disease; Pulmonary Function; Inflammatory Markers

Outcome Measures

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）

  Baseline to 24 weeks

Secondary Outcomes (14)

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

  Baseline to 24 weeks

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

  Baseline to 24 weeks

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

  Baseline to 24 weeks

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

  Baseline to 24 weeks

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

  Baseline to 24 weeks

Study Arms (2)

Tetrandrine Group

EXPERIMENTAL

Participants receive tetrandrine tablets (60 mg, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).

Drug: Tetrandrine Tablets

Placebo Group

PLACEBO COMPARATOR

Participants receive placebo tablets (mimicking tetrandrine, three times daily) for 24 weeks, along with standard treatment (glucocorticoids and immunosuppressants).

Drug: Placebo

Interventions

Tetrandrine Tablets DRUG

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

Tetrandrine Group

Placebo DRUG

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

Placebo Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 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

You may not qualify 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
• 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)

Sponsors & Collaborators

• Peking University Third Hospital: lead

Study Sites (1)

Peking University Third Hospital

Beijing, China

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Connective Tissue Diseases

Interventions

tetrandrine

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: January 6, 2026
• Study Start: November 2, 2023
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 6, 2026

Record last verified: 2025-08

Locations

CN (1)