Efficacy of Thymosin alpha1 for Severe Sepsis

Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00711620

Acronym

ETASS

Enrollment

366

Registered

2008-07-09

Start date

2008-05-31

Completion date

2011-01-31

Last updated

2011-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe Sepsis

Keywords

sepsis, Immunotherapy, Thymosin

Brief summary

The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.

Detailed description

Severe sepsis is a disease of infectious origin with a high risk of death. Over the past decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight against infectious diseases, but it is unknown whether thymosin alpha1 is effective in treating severe sepsis.

Interventions

DRUGThymosin alpha 1

1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Severe sepsis according to ACCP/CCM criteria * Patient or legally authorized representative able to provide informed consent

Exclusion criteria

* Subject is less than 18 years or more than 85 years of age * If female, the subject is pregnant or nursing * Subject is receiving immunosuppressive therapy such as cyclosporine, azothioprine,or cancer-related chemotherapy * Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end-stage disease * History of bone marrow, lung, liver, pancreas, or small-bowel transplantation * Acute pancreatitis with no established source of infection

Design outcomes

Primary

Measure	Time frame	Description
28-day Mortality	28 days	The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion.

Secondary

Measure	Time frame	Description
SOFA score	7 days	SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups.
Immune response to Thymosin alpha 1	7 days	HLA-DR expression on CD14+,ratio between CD4+ and CD8+, CRP on day 0, 3, 7 after the start of the infusion in both groups.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 24, 2026