RecruitingPhase 3

Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis

China272 participantsStarted 2022-06-07

Plain-language summary

This study is a randomized, double-blind, placebo-controlled, multicenter clinical study. The main purpose of this study was to confirm the efficacy and safety of pirfenidone capsules in the treatment of pneumoconiosis.

Who can participate

Age range18 Years – 70 Years

SexALL

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Inclusion criteria

✓.HRCT at screening showed diffuse interstitial changes in the lungs. 6. Patients voluntarily participated in this trial, with good compliance, and had the ability to understand and sign informed consent before the study.

Exclusion criteria

✕. Severe hypertension within 6 weeks and uncontrolled with treatment (≥160/100 mmHg);
✕. Myocardial infarction within 6 months;
✕. Unstable angina within 6 months. 10. Coagulation parameters: International normalized ratio (INR) \> 2, prothrombin time (PT) prolongation \> 1.5 times ULN.

What they're measuring

Changes in pulmonary function FVC%

Timeframe: 52 weeks

Trial details

NCT IDNCT05288179

SponsorBeijing Continent Pharmaceutical Co, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-30

Contact for this trial

Ling Zhang, Dr

13501209210 zhangling@bjcontinent.com

View on ClinicalTrials.gov More Pneumoconiosis trials