A Phase ll Study to evaluate the efficacy and safety of various doses of HEC585 Tablets in patients with idiopathic pulmonary fibrosis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
270
HEC585 Tablets,once daily
Pirfenidone,three times a day
Placebo,once daily
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China
Change from Baseline to Week 24 in %FVC compared with placebo
change in %FVC, measured using Spirometer, from baseline to week 24
Time frame: 24 Weeks
Change from Baseline to Week 24 in %FVC compared with Pirfenidone
change in %FVC, measured using Spirometer, from baseline to week 24
Time frame: 24 Weeks
Change from Baseline to Week 12 in %FVC compared with placebo/ Pirfenidone
change in %FVC, measured using Spirometer, from baseline to week 12
Time frame: 12 Weeks
Proportion of subjects with an absolute decline from baseline in FVC (% predicted) of > 10%
The proportion of subjects whose %FVC decline from baseline by more than 10% in each treatment group at W24
Time frame: 24 Weeks
Time to first acute IPF exacerbation
Time frame: 24 Weeks
All-cause mortality
Time frame: 24 Weeks
IPF related mortality
Time frame: 24 Weeks
Changes of 6MWT results
Time frame: 12 Weeks, 24 Weeks
Changes of SGRQ scores
Time frame: 12 Weeks, 24 Weeks
Changes of DLco (Hb correction)
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Time frame: 12 Weeks, 24 Weeks
Changes of resting SpO2
Time frame: 12 Weeks, 24 Weeks