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RECRUITING
NCT05828953
PHASE2/PHASE3

Anlotinib Capsules in the Treatment for IPF/PF-ILDs

Sponsor: First Affiliated Hospital of Wenzhou Medical University

View on ClinicalTrials.gov

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

Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial of Anlotinib Capsules for the Treatment of Idiopathic Pulmonary Fibrosis (IPF)/Progressive Fibrosis-interstitial Lung Disease (PF-ILDs)

Key Details

Gender

All

Age Range

40 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2021-09-28

Completion Date

2026-09-09

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

Anlotinib

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 24 weeks as the primary endpoint, to observe the long-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs. After 24 weeks, the blinded administration was continued until 52 weeks. After 52 weeks, all subjects could enter the extension period if they wished. 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 24 weeks as the primary endpoint, to observe the long-term efficacy and safety of anlotinib in the treatment of IPF/PF-ILDs. After 24 weeks, the blinded administration was continued until 52 weeks. After 52 weeks, all subjects could enter the extension period if they wished. If a dose is missed and the next dose is due within 12 hours, it should not be made up.

Locations (1)

The First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China