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Efficacy and safety of pirfenidone in the treatment of progressive fibrosing interstitial lung disease (PF-ILD)

Efficacy and safety of pirfenidone in the treatment of progressive fibrosing interstitial lung disease (PF-ILD)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042720
Enrollment
Unknown
Registered
2021-01-26
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial lung disease

Interventions

experimental group:Treatment with pirfenidone
control group:Nil

Sponsors

Shanghai Pulmonary Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients with pf-ild diagnosed as non IPF; 2. Patients over 18 years old; 3. The patients with diffuse fibrotic pulmonary disease (reticular shadow with tractive bronchiectasis, with or without honeycomb lung) showed more than 10% degree by HRCT examination = 45%; 5. Patients with DLCO predicted value >= 30% - < 80%; 6. Patients with informed consent.

Exclusion criteria

Exclusion criteria: 1. Subjects allergic to pirfenidone capsules; 2. In subjects with abnormal liver function, serum alanine aminotransferase, aspartate aminotransferase or bilirubin increased more than 2 times at baseline; 3. Subjects who had received other research drugs (participating in clinical research) within 8 weeks before visit 1; 4. Subjects who had received nidanib treatment within 8 weeks before visit 1; 5. Subjects who had been treated with pirfenidone before; 6. Women of childbearing age who plan to get pregnant or men of childbearing age who plan to have children; 7. Pregnant or lactating women; 8. Patients with other serious persistent diseases or organ system dysfunction (the researchers believe that it may damage the safety of patients or interfere with the safety evaluation of the test drug); 9. Compliance: subjects with known evidence of non-compliance with the trial drug treatment and / or failure to follow the doctor's advice.

Design outcomes

Primary

MeasureTime frame
Lung Function;

Secondary

MeasureTime frame
King's short questionnaire for interstitial lung disease;Time of acute exacerbation of interstitial lung disease;

Countries

China

Contacts

Public ContactYing Zhou

Shanghai Pulmonary Hospital Affiliated to Tongji University

docyingzhou@163.com+86 13917152661

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026