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

Radiation-induced Lung Injury Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03902509
• Other study ID #: RP-F647-201901
• Status: Terminated
• Phase: Phase 2
• Start date: May 24, 2019
• Est. completion date: June 13, 2022

Study information

• Verified date: June 2022
• Source: Beijing Continent Pharmaceutical Co, Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

The study is a randomized, controlled, multi-site clinical trial.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 126
• Est. completion date: June 13, 2022
• Est. primary completion date: June 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. 18-75 years old (including 18 and 75 years);

2. clinically diagnosed grade 2 or 3 radiation-induced lung injury;

3. the course of radiation-induced lung injury is less than 2 months;

4. ECOG 0-2;

5. the expected survival time is more than 6 months;

6. 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

7. capable of eating solid food upon enrollment;

8. subjects will voluntarily participate in this study and sign the informed consent.

Exclusion Criteria:

1. have a history of chronic bronchial acute attack or severe pulmonary heart disease;

2. pneumonectomy;

3. tumor progression;

4. severe pulmonary infection;

5. creatinine clearance rate < 30ml/min, severe renal disease or need dialysis;

6. 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;

7. patients with active peptic ulcer;

8. pregnant women and patients with mental illness;

9. participating in clinical trials of other drugs within 3 months;

10. the investigator determined that subject was not suitable.

Related Conditions & MeSH terms

• Lung Injury
• Radiation-induced Lung Injury
• Wounds and Injuries

Intervention

Drug:
• Pirfenidone
pirfenidone capsule made in China
• basic treatment
glucocorticoid and expectant treatment etc.

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Science	Beijing	Beijing
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Continent Pharmaceutical Co, Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DLco% change	Compare DLco% from basement to the end of treatment	Week 8 and 24
Secondary	The grade change of radiation-induced lung injury		Week 8 and 24
Secondary	The score change of CT		Week 8 and 24
Secondary	Increase of effective lung volume		Week 8 and 24
Secondary	The grade change of Cough, Dyspnea and Fever		Week 8 and 24