Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
ConditionPneumoconiosis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBeijing Continent Pharmaceutical Co, Ltd.
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.
Eligibility criteria
Qualifiers
1. Age 18~70 years old (including 18 years old and 70 years old), gender is not limited.
Disqualifiers
1. Those who do not meet any of the inclusion criteria. 2. Those who have received lung lavage therapy within 3 months and plan to receive lung lavage therapy during the trial.
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.
Trial design
Treatments tested in this trial
- Pirfenidone Capsules
- placebo capsules
Treatment groups
272 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov