Completed
PHASE3
INTERVENTIONAL
NCT02867267
The Efficacy and Safety of Ta1 for Sepsis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis
Detailed Description
Our previous study reported that the 7-day treatment of Ta 1 demonstrated positive active effect as to the 28-day all-cause mortality and the augmentation of mHLA-DR (monocyte Human Leukocyte Antigen DR) at the secondary endpoint. Therefore, we intend to verify this finding through a randomized, double-blind and placebo-controlled clinical trial and the trail will include subjects with impaired immunologic functions.
Interventions
Name:
Thymosin alpha 1
Type:
DRUG
Description:
Subcutaneous injections of 1.6 mg thymosin alpha 1 every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
Name:
Placebo
Type:
OTHER
Description:
Subcutaneous injections of placebo every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
Primary Outcomes
Measure:
28-day all-cause mortality
TimeFrame:
28 days
Description:
Trial Information
NCT ID
NCT02867267
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE3
Sponsor
Sun Yat-sen University
Last Updated
December 15, 2025