Created at Source Raw Value Validated value
May 22, 2021, 12:32 a.m. usa

(1) ast and alt> 1.5 x uln at visit 1; (2) bilirubin> 1.5 x uln at visit 1; (3) creatinine clearance rate calculated by cockcroft-gault formula at visit 1 <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) screening visits (interviews 1) received other research drug treatment within 1 month or 6 half-lives (whichever is greater); (7) ipf diagnosis based on ats / ers / jrs / alat 2011 guidelines (p11-07084); (8 ) significant pulmonary hypertension (pah) defined by any of the following standards: ① clinical / echocardiographic evidence of previously significant right heart failure; ② medical history including right heart catheter showing a cardiac index ≤ 2l / min / m2; ③ prostaglandol / qu parenteral administration of prostacyclin in the treatment of pah; (9) other clinically significant lung abnormalities considered by the investigator; (10) major extrapulmonary physiological limitations (such as chest wall deformity, large amount of pleural effusion); (11) cardiovascular diseases, 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; ③ unstable angina within 6 months of visit 1; (12) history of severe central nervous system (cns) events; (13) known trials drug allergies; (14) other diseases that may interfere with the testing process or as judged by the investigator may interfere with the trial participation or may put the patient at risk when participating in the trial; (15) women who are pregnant, breastfeeding, or planning pregnancy 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) creatinine clearance rate calculated by cockcroft-gault formula at visit 1 <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) screening visits (interviews 1) received other research drug treatment within 1 month or 6 half-lives (whichever is greater); (7) ipf diagnosis based on ats / ers / jrs / alat 2011 guidelines (p11-07084); (8 ) significant pulmonary hypertension (pah) defined by any of the following standards: ① clinical / echocardiographic evidence of previously significant right heart failure; ② medical history including right heart catheter showing a cardiac index ≤ 2l / min / m2; ③ prostaglandol / qu parenteral administration of prostacyclin in the treatment of pah; (9) other clinically significant lung abnormalities considered by the investigator; (10) major extrapulmonary physiological limitations (such as chest wall deformity, large amount of pleural effusion); (11) cardiovascular diseases, 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; ③ unstable angina within 6 months of visit 1; (12) history of severe central nervous system (cns) events; (13) known trials drug allergies; (14) other diseases that may interfere with the testing process or as judged by the investigator may interfere with the trial participation or may put the patient at risk when participating in the trial; (15) women who are pregnant, breastfeeding, or planning pregnancy in this trial (16) patients are unable to understand or follow the trial procedures, including completing the questionnaires themselves without assistance.