Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-25 @ 2:36 AM
NCT ID:
NCT01504334
Eligibility Criteria:
Inclusion Criteria:
1. Written informed consent signed;
2. 18-75 years of age;
3. Clinically or multidisciplinarily diagnosed idiopathic pulmonary fibrosis(see 2011 guidance );
4. Resting state PaO2≥50mg, FVC%≥45% normal predicted value and DLCO≥30% normal predicted value.
Exclusion Criteria:
1. Allergic to pirfenidone;
2. Dyspnea symptoms relieved in the past 6 months;
3. Patients in acute exacerbation phase;
4. Diabetic patients whose fasting venous glucose \>11.1 mmol/L;
5. Patients with malignant tumor and hemorrhagic diseases;
6. Patients with serious underlying pulmonary disease;
7. Patients with serious heart disease(NYHA class Ⅲ-Ⅳ), liver disease(ALT or AST 2 times above the upper level of normal value range), kidney disease(Cr above the upper level of normal value range);
8. Patients who has taken Acetylcysteine in the past 3 months;
9. Patients who has taken Prednisone\>15mg/day(or other equivalent amount of glucocorticoid) and/or Immunosuppresants in the past 3 months;
10. Patients who has taken interferon, penicillamine, colchine or other agents for the treatment of IPF;
11. Pregnant or lactating women;
12. Participated in other clinical trials in the past 1 month;
13. The investigator assessed as inappropriate to participate in this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT01504334
Study Brief:
Protocol Section:
NCT01504334