Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis

NCT ID: NCT02883595

Last Updated: 2019-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

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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

Detailed Description

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Part 1: To observe the function of thymosin alpha 1 in sepsis patients via improving phagocytosis, bacteria eradication and antigen-presenting on monocyte Part 2: Pharmacokinetics of thymosin alpha 1 for sepsis

Conditions

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Sepsis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

thymosin alpha 1

Intervention Type DRUG

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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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thymosin alpha 1

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.

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Other Intervention Names

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thymalfasin

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Wu Jianfeng

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Wu Jianfeng, M. D

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

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Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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thymosin alpha 1

Identifier Type: -

Identifier Source: org_study_id

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