CompletedPhase 2

A Study About Safety and Efficacy of Pirfenidone to Treat Grade 2 or Grade3 Radiation-induced Lung Injury.

China126 participantsStarted 2019-05-24

Plain-language summary

Using Pirfenidone to treat Grade 2 or Grade3 radiation-induced lung injury, and observe the efficacy and safety of the drug.

Age range18 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 18-75 years old (including 18 and 75 years);
✓. clinically diagnosed grade 2 or 3 radiation-induced lung injury;
✓. the course of radiation-induced lung injury is less than 2 months;
✓. ECOG 0-2;
✓. the expected survival time is more than 6 months;
✓. the functional level of major organs meets the following standards: ANC≥3.0×109/L，PLT≥100×109/L，Hb≥90g/L, TBIL、BUN and Cr≤1.5×ULN， ALT、AST≤2.0×ULN
✓. capable of eating solid food upon enrollment;
✓. subjects will voluntarily participate in this study and sign the informed consent.

✕. have a history of chronic bronchial acute attack or severe pulmonary heart disease;
✕. pneumonectomy;
✕. tumor progression;
✕. severe pulmonary infection;
✕. creatinine clearance rate \< 30ml/min, severe renal disease or need dialysis;
✕. concomitant with other serious diseases: for example, myocardial infarction within 6 months, uncontrolled diabetes, etc., were considered not suitable for the participants in the study;
✕. patients with active peptic ulcer;
✕. pregnant women and patients with mental illness;

DLco% change

Timeframe: Week 4, 8,16, and 24

NCT IDNCT03902509

SponsorBeijing Continent Pharmaceutical Co, Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-04