Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2026-02-20 @ 10:21 AM
Study NCT ID:
NCT02883595
Status:
COMPLETED
Last Update Posted:
2019-04-04
First Post:
2016-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077596', 'term': 'Thymalfasin'}], 'ancestors': [{'id': 'D013947', 'term': 'Thymosin'}, {'id': 'D013951', 'term': 'Thymus Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2016-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-02', 'studyFirstSubmitDate': '2016-08-10', 'studyFirstSubmitQcDate': '2016-08-24', 'lastUpdatePostDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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,', 'timeFrame': '28days', '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'}], 'secondaryOutcomes': [{'measure': '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', 'timeFrame': '28 days', 'description': 'Concentration of Ta 1 was measured on day 0, 3 and 7 after injection drug or placebo'}, {'measure': 'Maximum observed serum concentration (Cmax) of Ta 1', 'timeFrame': '7 days'}, {'measure': 'Area under the serum concentration-time curve from time zero to time of last quantifiable concentration (AUC(0-T)) of Ta 1', 'timeFrame': '7 days'}, {'measure': 'Terminal serum half-life (T-HALF) of Ta 1', 'timeFrame': '7 days'}, {'measure': 'Time of maximum observed serum concentration (Tmax) of Ta 1', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['thymosin alpha 1; sepsis; monocyte; pharmacokinetics'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent from the patients or their next of kin for patients unable to consent\n2. Age ≥18 yrs\n3. Presence of sepsis/ septic shock according to sepsis 3.0\n\nExclusion Criteria:\n\n1. Pregnant or lactation period.\n2. Age \\<18 yrs\n3. Receiving immunosuppressive therapy such as cyclosporine, azathioprine or cancer chemotherapy within one month.\n4. History of bone marrow, lung, liver, kidney, pancreas or small bowel transplantation;\n5. Acute pancreatitis with no established source of infection.\n6. Not expected to survive 28 days because of end-stage diseases.\n7. Participation in another clinical trial.'}, 'identificationModule': {'nctId': 'NCT02883595', 'briefTitle': 'Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Efficacy of Thymosin Alpha 1 on Improving Monocyte Function for Sepsis', 'orgStudyIdInfo': {'id': 'thymosin alpha 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'thymosin alpha 1', 'description': '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.', 'interventionNames': ['Drug: thymosin alpha 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subcutaneous injections of placebo (saline) twice per day for seven days', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'thymosin alpha 1', 'type': 'DRUG', 'otherNames': ['thymalfasin'], 'description': '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.', 'armGroupLabels': ['thymosin alpha 1']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Subcutaneous injections of placebo (saline) twice per day for seven days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Wu Jianfeng, M. D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Affiliated Hospital, Sun Yat-Sen University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Wu Jianfeng', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}