Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

NCTNCT02883595Other idthymosin alpha 1

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Overview

Status: Completed
Phase: Phase 4
Enrollment: 20 participants (actual)
Sponsor: Sun Yat-sen University · Other
Design: Randomized · Quadruple masking
Countries: 1 country
China
Start: 31 Mar 2016
Primary completion: 30 Sept 2016
Completion: 31 Dec 2016
First posted: 30 Aug 2016 (estimated)
Last update posted: 4 Apr 2019
Conditions: Sepsis

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20162017

Ph 4
Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
NCT02883595
31 Mar 2016 to 31 Dec 2016

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to determine whether thymosin alpha 1 is effective on improving monocyte function and has the desired pharmacologic activity for sepsis

Interventions

thymosin alpha 1Drug
PlaceboOther

Arms2

Experimental
thymosin alpha 1
Subcutaneous injections of 1.6 mg thymosin alpha 1 twice per day for seven days, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
Placebo comparator
Placebo
Subcutaneous injections of placebo (saline) twice per day for seven days

Primary outcomes1

Outcomes the sponsor listed as primary.

Ta 1 improving immune function of monocyte for sepsis, used by flow cytometric to measure phagocytosis(CD11b, CD64), antigen presenting(HLA-DR, CD86 and PD-L1), and apoptosis(active caspase 3) on monocyte,
Time frame · 28days
Registry description
Phagocytosis was measured by expression of monocyte surface antigen CD64 and CD11b, as well as pHrodo™ BioParticles® Phagocytosis Kits to assessing phagocytic activity on monocyte; antigen presenting was measured by HLA-DR, costimulatory molecule CD86 and inhibitory molecule PD-L1 on monocyte; apoptosis was measured by active caspase 3 on monocyte

Secondary outcomes(5)

Relationship between concentration of Ta 1 and prognosis of sepsis patients, measured by concentration of Ta 1, 28-day all-cause mortality, 28-day clearance rate of pathogenic microorganism, ICU stays and hospital stays
Time frame · 28 days
Registry description
Concentration of Ta 1 was measured on day 0, 3 and 7 after injection drug or placebo
Maximum observed serum concentration (Cmax) of Ta 1
Time frame · 7 days
Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1
Time frame · 7 days
Terminal serum half-life (T-HALF) of Ta 1
Time frame · 7 days
Time of maximum observed serum concentration (Tmax) of Ta 1
Time frame · 7 days

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Written informed consent from the patients or their next of kin for patients unable to consent 2. Age ≥18 yrs 3. Presence of sepsis/ septic shock according to sepsis 3.0 Exclusion Criteria: 1. Pregnant or lactation period. 2. Age \<18 yrs 3. Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month. 4. History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation; 5. Acute pancreatitis with no established source of infection. 6. Not expected to survive 28 days because of end-stage diseases. 7. Participation in another clinical trial.

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