- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05288179
Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
A Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial of Efficacy and Safety of Pirfenidone Capsules in the Treatment of Pneumoconiosis
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: ling zhang, Dr
- Phone Number: +86 13501209210
- Email: zhangling@bjcontinent.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 of predicted value %FVC≥40% and <80% 4. The percentage of carbon monoxide dispersion in the predicted value at the time of screening %DLCO≥30% and <80%.
5.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:
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.
3. ALT or AST > 3 times ULN. 4. TBiL > 2 times ULN. 5. Creatinine clearance <30 mL/min. 6. Patients with co-infection or high fever within 4 weeks prior to screening, including but not limited to acute bronchitis, pneumonia, sinusitis, urinary tract infection, or cellulitis.
7. Combined with tuberculosis or lung cancer. 8. Significant pulmonary arterial hypertension requiring parenteral therapy with epoprostenol/treprostinil or severe right heart failure determined by the investigator to be unsuitable to participate in the trial.
9. Severe cardiovascular disease with one of the following conditions:
- 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.
11. Other conditions or comorbidities that may interfere with testing procedures (eg, intolerance to interruption of supplemental oxygen during pulmonary function tests) or, based on the investigator's judgment, that may interfere with trial participation or that may put patients at risk.
12. Patients with dysphagia or clinical signs of malabsorption or who require parenteral nutrition.
13. With active peptic ulcer. 14. History of thrombotic events (including stroke and transient ischemic attack) within 12 months.
15. Use of cytotoxic drugs, immunosuppressive drugs, cytokine-modulating drugs, or receptor antagonist drugs such as azathioprine, cyclophosphamide, cyclosporine, etanercept, infliximab, white Triene antagonists, methotrexate, tacrolimus, TNF-α inhibitors and tyrosine kinase inhibitors TKIs and other drugs.
16. Use of interferon, bisbenzylisoquinoline alkaloids (tetrandrine), polyethylene pyrimidine nitroxide (gramsilpine), quinape phosphate, hydroxyquinoline phosphate, aluminum citrate within 1 month before randomization , nintedanib, or high-dose acetylcysteine.
17. Patients who have previously used drugs that may cause pulmonary fibrosis, such as amiodarone, or have been exposed to asbestos, beryllium and other substances, or exposed to radioactive environments.
18. Hypersensitivity to the investigational drug or its components (eg, lactose).
19. Investigator judges that life expectancy due to other medical conditions is < 2.5 years.
20. Major surgery planned during treatment. 21. Women who were pregnant, breastfeeding, or planning to become pregnant during the trial.
22. Women of childbearing age who are unwilling or unable to use a highly effective method of contraception during the 28 days before or 3 months after dosing.
23. According to the researcher, the patient is either alcohol or drug abuser. 24. mentally ill. 25. Those who participated in clinical trials of other drugs within 3 months. 26. Investigators judged to be unfit to participate in the trial.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pirfenidone group
Patient takes pirfenidone 3 times a day,Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time
|
After randomization, the experimental group took pirfenidone capsules 3 times a day,Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time
Other Names:
|
Placebo Comparator: placebo group
Patients take a placebo 3 times a day,Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time
|
After randomization, the experimental group took placebo capsules 3 times a day,Week 1, 2 capsules/time; Week 2, 4 capsules/time; Week 3-52, 6 capsules/time
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in pulmonary function FVC%
Time Frame: 52 weeks
|
Change in FVC % (FVC % predicted) at 52 weeks of treatment
|
52 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary function FVC
Time Frame: 52 weeks
|
Changes in FVC (L) at 52 weeks of treatment
|
52 weeks
|
Changes in lung function DLco%
Time Frame: 52 weeks
|
Change in DLco% at 52 weeks of treatment
|
52 weeks
|
Collaborators and Investigators
Investigators
- Principal Investigator: Huaping Dai, Dr, China-Japan Friendship Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Occupational Diseases
- Lung Diseases, Interstitial
- Lung Injury
- Pneumoconiosis
- Physiological Effects of Drugs
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Pirfenidone
Other Study ID Numbers
- GNI-F647-202101
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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