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About
The purpose of this study is to assess the efficacy and safety of the intravenous drip infusion of ART-123 in patients with acute exacerbation of idiopathic pulmonary fibrosis (IPF) in a multicenter, double-blind, randomized, placebo-controlled, parallel group comparison study, and to confirm its superiority over placebo with survival rate on Day 90 as the primary endpoint.
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Inclusion and exclusion criteria
Main Inclusion Criteria:
Patients diagnosed with IPF who meet all criteria from (1) through (4) during the course of IPF
(1)Unexplained development or worsening of dyspnea within 1 month during the course of IPF
(2)Finding of new, bilateral ground glass opacities and/or consolidation on HRCT
(3)No apparent Pulmonary infections, pneumothorax, malignant tumors, pulmonary embolism, or left heart failure
(4)A decrease* in PaO2 of ≥10 mmHg or SpO2 of ≥4% under the same conditions compared with the level at the previous measurements
Aged 40 years or older and no older than 85 years at the time of informed consent with either sex
Main Exclusion Criteria:
Primary purpose
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Interventional model
Masking
74 participants in 2 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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