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Tests treatment safety and results for Pneumoconiosis
Official title Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
ClinicalTrials.gov ID: NCT05288179
What this study is testing
What is Pirfenidone Capsules?
Pirfenidone Capsules is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for pneumoconiosis.
Also referred to as F647.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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 of predicted value %FVC≥40% and \<80% 4. The percentage of carbon monoxide dispersion in the...
- 5.HRCT at screening showed diffuse interstitial changes in the lungs. 6. Patients voluntarily participated in this trial, with good compliance, and...
You likely can't join if
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.