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Clinical Trial Summary

This trial was performed in patients with idiopathic pulmonary fibrosis (IPF) to evaluate the clinical efficacy and safety of different doses of TDI01 Suspension, compared with control, for the treatment of patients with IPF.


Clinical Trial Description

This is a Phase II, multi-center, randomized, double-blinded, placebo-controlled clinical study to evaluate the efficacy and safety of TDI01 Suspension for the treatment of IPF. The study consists of a 4-week screening period, a 24-week treatment period, a 28-week extension period, and a 2-week safety follow-up period. It is planned to include 120 IPF patients. All subjects will be randomized in a 1:1:1 ratio to receive a 24-week treatment with TDI01 Suspension dosage A, TDI01 Suspension dosage B, or the placebo. At Week 24, the subjects will be evaluated for the primary efficacy endpoints and subsequently enter the extension period. Subjects may continue receiving the investigational product until Week 52 at their voluntary consent. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06102083
Study type Interventional
Source Beijing Tide Pharmaceutical Co., Ltd
Contact Dai HuaPing, MD
Phone 010-84206278
Email daihuaping@ccmu.edu.cn
Status Not yet recruiting
Phase Phase 2
Start date November 2, 2023
Completion date March 1, 2026

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