Anlotinib Capsules in the Treatment for IPF/PF-ILDs

Status Recruiting

Clinical Trial Summary

The use of Anlotinib hydrochloride capsules for the treatment of IPF/PF-ILDs, with FVC as the primary efficacy endpoint to evaluate its effectivenes

Clinical Trial Description

Drug: Anlotinib The dose of nintedanib hydrochloride is 8mg per dose, taken orally once daily before breakfast. The drug is taken continuously for 2 weeks, followed by a 1-week break, until week 52, disease progression, or the occurrence of intolerable adverse events. If a dose is missed and the next dose is due within 12 hours, it should not be made up. Drug: Placebo Placebo, taken orally once daily before breakfast. Taken continuously for 2 weeks, followed by a 1-week break, until week 52, disease progression, or the occurrence of intolerable adverse events. If a dose is missed and the next dose is due within 12 hours, it should not be made up. FVC stands for forced vital capacity, which is typically the maximum amount of air that can be forcefully exhaled after taking a deep breath as quickly and completely as possible. This measure primarily assesses the ability to exhale as much air as possible in the shortest amount of time, and is used as an indicator of lung function.The change in FVC from baseline at week 52 after administration. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05828953
Study type	Interventional
Source	First Affiliated Hospital of Wenzhou Medical University
Contact	Dan Yao, Master
Phone	0577-55579271
Email	zdyaodan@163.com
Status	Recruiting
Phase	Phase 2/Phase 3
Start date	September 28, 2021
Completion date	July 1, 2024

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