Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
Recruiting
Phase 3
Interventional Study
Pneumoconiosis
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 70
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 272 (estimated)
- Sponsor
- Beijing Continent Pharmaceutical Co, Ltd. · Industry
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About This Trial
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 1\. Age 18\~70 years old (including 18 years old and 70 years old), gender is not limited.
2\. Diagnosed with silicosis or coal worker's pneumoconiosis, in line with GBZ 70-2015 "Diagnosis of Occupational Pneumoconiosis".
3\. Forced vital capacity at screening percentage…
Contacts