A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decli… (NCT05139719) | Clinical Trial Compass
RecruitingPhase 2
A Study to Explore the Therapeutic Effect of HEC585 on Delaying Forced Vital Capacity (FVC) Decline and Tolerance in Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Patients
China110 participantsStarted 2023-02-15
Plain-language summary
The main goal of this phase llb study is to compare the efficacy and safety of two doses of HEC585 tablets with placebo which is a look-alike substance that contains no active drug in patients with progressive fibrosing interstitial lung diseases. This study is divided into two stages, i.e. main study stage with 24 weeks treatment duration followed by up to 96 weeks treatment extended study stage.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Volunteer to participate and sign the ICF.
✓. Male or female patients' age ≥ 18 years when signing the ICF.
✓. Patients with known or unknown etiology (except IPF) and clear pulmonary fibrosis on chest CT have undergone conventional clinical treatment (assessed by the investigator, including follow-up observation) for ≥ 3 months. At least two of the following criteria occurring within 12 months before screening without alternative explanation (such as infection, heart failure, etc.):
✓. absolute FVC (% of predicted) decline ≥ 5%.
✓. absolute DLco\[Hb corrected\] (% of predicted) decline ≥ 10%. iii) Radiological evidence of disease progression (one or more of the following):
✓. Increased extent or severity of traction bronchiectasis and bronchiolectasis.
✓. New ground-glass opacity with traction bronchiectasis.
✓. New fine reticulation.
Exclusion criteria
✕. Diagnosis of Idiopathic Pulmonary Fibrosis (IPF).
✕. Lung with other clinically significant abnormalities which the investigator assess to have an effect on the results of study.
✕. Significant Pulmonary Arterial Hypertension (PAH), such as meeting the following: Previous clinical or echocardiographic evidence of significant right heart failure, History of right heart catheterization showing a cardiac index ≤ 2 L/min/m², or PAH requiring parenteral therapy with epoprostenol/treprostinil.
What they're measuring
1
Change from Baseline to Week 24 in FVC (mL) compared with placebo