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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.
Full 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.
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Inclusion and exclusion criteria
Inclusion Criteria
Exclusion Criteria
Subjects are not eligible for participation in the study if they meet any of the following exclusion criteria:
Primary purpose
Allocation
Interventional model
Masking
120 participants in 3 patient groups, including a placebo group
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Central trial contact
Dai HuaPing, MD
Data sourced from clinicaltrials.gov
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