This is a multi-center, randomized, double-blinded, and placebo-controlled phase II study to evaluate the efficacy and safety of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
91
Patients were administered Jaktinib taken orally as tablets twice daily
Patients were administered Jaktinib taken orally as tablets twice daily
Patients were administered Placebo taken orally as tablets twice daily
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
Changes in forced vital capacity (FVC) [ Time Frame: 24 weeks ]
Changes in FVC from 24 weeks to baseline
Time frame: 24 weeks
Progression-free time [ Time Frame: the onset of disease or death from any cause ]
The time from a random date to the onset of disease or death from any cause;
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 48 months
Non-worsening survival time: [ Time Frame:the time from randomization to the first acute exacerbation ];
acute aggravation events should meet all the following conditions: (1) acute exacerbation or aggravation of respiratory distress within 1 month;Chest CT showed new bilateral ground glass shadows or pulmonary interstitial fibrosis with pulmonary consolidation;(3) exclude heart failure, fluid retention and infection caused by acute dyspnea
Time frame: from randomization to one month
K-BILD Scale: absolute value of change from baseline [ Time Frame: 24 weeks ]
absolute value of change from baseline at 24 weeks
Time frame: 24 weeks
mMRC Dyspnea scale:absolute value of change from baseline [ Time Frame: 24 weeks ]
absolute value of change from baseline at 24 weeks
Time frame: 24 weeks
Survival rate: [ Time Frame: 6 months, 12 months, 24 months ]
Survival rate
Time frame: 6 months, 12 months, 24 months
The severity and incidence of all adverse events and adverse reactions[ Time Frame: within 28 days after the signing of the informed consent]
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The severity and incidence of all adverse events and adverse reactions
Time frame: within 28 days after the signing of the informed consent