CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,106 enrolled
Drug / intervention
Thymosin alpha 1 +1 moredrug
Likely dose
Thymosin alpha 1 1.6 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02867267
NCT02867267Phase 3Completed

The Efficacy and Safety of Thymosin Alpha 1 for Sepsis: a Multicenter , Double-Blinded, Randomized and Controlled Clinical Trial

Sun Yat-sen University·interventional·Posted Aug 15, 2016·Updated Apr 10, 2023

In Brief

A Phase 3 clinical trial evaluating Thymosin alpha 1 and Placebo for Sepsis. Completed, enrolled 1,106 participants across 22 sites.

Detailed Summary

The purpose of this study is to determine whether thymalfasin is safe and effective in patients who have sepsis

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSepsis
CountriesChina

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 15, 2016
Enrollment StartSep 6, 2016
Primary CompletionJan 22, 2021
Study CompletionMar 23, 2021
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 9.9 years ago

Interventions

Thymosin alpha 1drug

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.

Placeboother

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.