Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

1. AST and ALT> 1.5 x ULN at visit 1, 2. bilirubin> 1.5 x ULN at visit 1, 3. At visit 1, calculated by Cockcroft–Gault formula, creatinine clearance <30 mL / min, 4. Patients with potential chronic liver disease (Child Pugh A, B or C liver injury), 5. Previous treatment with nidanib or pirfenidone, 6. One month before the screening visit (Visit 1) or 6 half-lives (whichever is greater) were treated with other research drugs, 7. Diagnosis of IPF based on ATS/ERS/JRS/ALAT2011 guidelines (p11-07084), 8. Significant pulmonary hypertension (PAH) defined by any of the following criteria: (1) Clinical / echocardiographic evidence of previously significant right heart failure, (2) History including right heart catheterization showing a cardiac index <=2 l / min / m2, (3) Prostaglandin required Parenteral administration of Treprostinil for PAH 9. Other clinically significant pulmonary abnormalities that the investigators believe, 10. Major extrapulmonary physiological limitations (eg, chest wall deformity, large pleural effusion), 11. Cardiovascular disease, any of the following diseases: (1) Severe hypertension within 6 months of visit 1, uncontrollable after treatment (>=160 / 100 mmHg) (2) Myocardial infarction within 6 months of visit 1, Unstable angina pectoris within 6 months of Visit 1, 12. History of severe central nervous system (CNS) events, 13. Known allergy to test drug, 14. Other diseases that may interfere with the testing process or that the investigator judges may interfere with the trial participation or may put patients at risk when participating in the trial, 15. Women who were pregnant, lactating or planning to become pregnant in this trial, 16. Patients are unable to understand or follow the trial procedures, including completing the questionnaires themselves without assistance.

1. AST and ALT> 1.5 x ULN at visit 1, 2. bilirubin> 1.5 x ULN at visit 1, 3. At visit 1, calculated by Cockcroft–Gault formula, creatinine clearance <30 mL / min, 4. Patients with potential chronic liver disease (Child Pugh A, B or C liver injury), 5. Previous treatment with nidanib or pirfenidone, 6. One month before the screening visit (Visit 1) or 6 half-lives (whichever is greater) were treated with other research drugs, 7. Diagnosis of IPF based on ATS/ERS/JRS/ALAT2011 guidelines (p11-07084), 8. Significant pulmonary hypertension (PAH) defined by any of the following criteria: (1) Clinical / echocardiographic evidence of previously significant right heart failure, (2) History including right heart catheterization showing a cardiac index <=2 l / min / m2, (3) Prostaglandin required Parenteral administration of Treprostinil for PAH 9. Other clinically significant pulmonary abnormalities that the investigators believe, 10. Major extrapulmonary physiological limitations (eg, chest wall deformity, large pleural effusion), 11. Cardiovascular disease, any of the following diseases: (1) Severe hypertension within 6 months of visit 1, uncontrollable after treatment (>=160 / 100 mmHg) (2) Myocardial infarction within 6 months of visit 1, Unstable angina pectoris within 6 months of Visit 1, 12. History of severe central nervous system (CNS) events, 13. Known allergy to test drug, 14. Other diseases that may interfere with the testing process or that the investigator judges may interfere with the trial participation or may put patients at risk when participating in the trial, 15. Women who were pregnant, lactating or planning to become pregnant in this trial, 16. Patients are unable to understand or follow the trial procedures, including completing the questionnaires themselves without assistance.