Clinical Trials Logo

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

See also
  Status Clinical Trial Phase
Active, not recruiting NCT05984992 - The First-in-human Study of SRN-001 in Healthy Participants Phase 1
Active, not recruiting NCT04312594 - Study of Jaktinib Hydrochloride Tablets in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT03865927 - GKT137831 in IPF Patients With Idiopathic Pulmonary Fibrosis Phase 2
Completed NCT03979430 - Early Detection of Acute Exacerbation in Patients With Idiopathic Lung Fibrosis - a Pilot Study N/A
Enrolling by invitation NCT04905693 - Extension Study of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis Phase 3
Not yet recruiting NCT06241560 - A Study in People With Idiopathic Pulmonary Fibrosis to Test Whether Pirfenidone Influences the Amount of BI 1015550 in the Blood Phase 2
Terminated NCT04419558 - Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 3
Completed NCT03725852 - A Clinical Study to Test How Effective and Safe GLPG1205 is for Participants With Idiopathic Pulmonary Fibrosis (IPF) Phase 2
Terminated NCT03573505 - An Efficacy and Safety Study of BG00011 in Participants With Idiopathic Pulmonary Fibrosis Phase 2
Recruiting NCT04148157 - Quality of Life in IPF - Patient and Physician Perceptions
Completed NCT03222648 - Structured Exercise Training Programme in Idiopathic Pulmonary Fibrosis N/A
Not yet recruiting NCT06422884 - A Phase 2 Trial of ENV-101 in Patients With Lung Fibrosis (WHISTLE-PF Trial) Phase 2
Completed NCT02268981 - Effects of an Oxymizer® During Daytime in Patients With Pulmonary Fibrosis (IPF) N/A
Completed NCT02257177 - RCT (Randomized Control Trial) of TD139 vs Placebo in HV's (Human Volunteers) and IPF Patients Phase 1/Phase 2
Withdrawn NCT01524068 - A MultiCenter Study of Combined PEX, Rituximab, and Steroids in Acute Idiopathic Pulmonary Fibrosis Exacerbations Phase 2
Enrolling by invitation NCT01382368 - Acute Effect of Sildenafil on Exercise Tolerance and Functional Capacity in COPD, IPF and Post Pneumonectomy Patients Phase 4
Completed NCT01199887 - Trial Of IW001 in Patients With Idiopathic Pulmonary Fibrosis Phase 1
Completed NCT01110694 - Prospective Observation of Fibrosis in the Lung Clinical Endpoints Study
Active, not recruiting NCT02951416 - Clinical Course of Interstitial Lung Diseases: European IPF Registry and Biobank
Terminated NCT00981747 - Targeting Vascular Reactivity in Idiopathic Pulmonary Fibrosis Phase 2/Phase 3