NCT02883595

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_4 sepsis

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_4 sepsis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 31, 2016

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

April 4, 2019

Status Verified

April 1, 2019

Enrollment Period

6 months

First QC Date

August 10, 2016

Last Update Submit

April 2, 2019

Conditions

Sepsis

Keywords

thymosin alpha 1; sepsis; monocyte; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

  • 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,

    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

    28days

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

    28 days

  • Maximum observed serum concentration (Cmax) of Ta 1

    7 days

  • Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1

    7 days

  • Terminal serum half-life (T-HALF) of Ta 1

    7 days

  • Time of maximum observed serum concentration (Tmax) of Ta 1

    7 days

Study Arms (2)

thymosin alpha 1

EXPERIMENTAL

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.

Drug: thymosin alpha 1

Placebo

PLACEBO COMPARATOR

Subcutaneous injections of placebo (saline) twice per day for seven days

Other: Placebo

Interventions

thymosin alpha 1DRUG

Subcutaneous injections of 1.6 mg thymosin alpha 1 twice per day for seven days, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.

Also known as: thymalfasin
thymosin alpha 1
PlaceboOTHER

Subcutaneous injections of placebo (saline) twice per day for seven days

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Written informed consent from the patients or their next of kin for patients unable to consent
  • Age ≥18 yrs
  • Presence of sepsis/ septic shock according to sepsis 3.0

You may not qualify if:

  • Pregnant or lactation period.
  • Age \<18 yrs
  • Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month.
  • History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation;
  • Acute pancreatitis with no established source of infection.
  • Not expected to survive 28 days because of end-stage diseases.
  • Participation in another clinical trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Sepsis

Interventions

Thymalfasin

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ThymosinThymus HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptide HormonesPeptidesAmino Acids, Peptides, and ProteinsProteins

Study Officials

  • Wu Jianfeng, M. D

    First Affiliated Hospital, Sun Yat-Sen University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

August 10, 2016

First Posted

August 30, 2016

Study Start

March 31, 2016

Primary Completion

September 30, 2016

Study Completion

December 31, 2016

Last Updated

April 4, 2019

Record last verified: 2019-04

Locations

CN(1)