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Anlotinib Capsules in the Treatment for IPF/PF-ILDs

NCT05828953 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-17

No results posted yet for this study

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

Conditions

  • Interstitial Lung Diseases

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.

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

    collaborator INDUSTRY

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Principal Investigators

  • Xiaoying Huang, Docter · the first affiliated hospital of wenhzou medical university

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-28
Primary Completion
2026-03-04
Completion
2026-09-09

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05828953 on ClinicalTrials.gov