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Efficacy of Thymosin alpha1 for Severe Sepsis
Plain-language guide to NCT00711620: not phased randomized trial of Thymosin Alpha-1, 366 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00711620
- Phase
- not phased
- Status
- completed
- Start
- 2008-05
- Completion (planned or actual)
- 2010-12
- Participants
- 366 (actual)
- Design
- randomized, double-blind, treatment
- Conditions studied
- Severe Sepsis
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered not phased trial tested Thymosin Alpha-1.
It had two arms (groups): Thymosin alpha 1+Standard Therapy (experimental) and normal saline+standard therapy (placebo comparator).
Patients receive treatment based on SSC guideline with additional thymosin alpha1.
Patients receive treatment based on SSC guideline with additional normal saline.
The registry classes the interventions as drug.
Who Took Part
The registry lists 366 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Severe sepsis according to ACCP/CCM criteria. Patient or legally authorized representative able to provide informed consent.
The full record lists 2 inclusion and 6 exclusion criteria; among the exclusions: 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.
How the Study Was Run
The set-up was randomized, parallel-group and double-blind.
The participants were allocated by chance, so the Thymosin Alpha-1 group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Blinding on both sides kept the participants and researchers unaware of who received Thymosin Alpha-1.
Those kept unaware of assignments: participant and outcomes assessor.
It started in 2008-05 with completion listed for 2010-12.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: 28-day Mortality (time frame: 28 days).
It also tracked 2 secondary outcomes, for example SOFA score and Immune response to Thymosin alpha 1.
What This Means in Plain Language
Put simply, this is a not phased, randomized trial of Thymosin Alpha-1 in 366 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Thymosin Alpha-1 compound page, all human trials.
Our Notes on the Compound
Thymosin Alpha-1: An immune-modulating thymic peptide that recalibrates T-cell function.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.