Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-05-06 @ 6:18 AM
Study NCT ID:
NCT00711620
Status:
COMPLETED
Last Update Posted:
2011-06-14
First Post:
2008-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Thymosin alpha1 for Severe 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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 366}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-06-13', 'studyFirstSubmitDate': '2008-06-27', 'studyFirstSubmitQcDate': '2008-07-03', 'lastUpdatePostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '28-day Mortality', 'timeFrame': '28 days', 'description': 'The prospectively defined primary end point was death from any cause and was assessed 28 days after the start of the infusion.'}], 'secondaryOutcomes': [{'measure': 'SOFA score', 'timeFrame': '7 days', 'description': 'SOFA score was measured on day0, 3 and 7 after the start of the infusion in both groups.'}, {'measure': 'Immune response to Thymosin alpha 1', 'timeFrame': '7 days', 'description': 'HLA-DR expression on CD14+,ratio between CD4+ and CD8+, CRP on day 0, 3, 7 after the start of the infusion in both groups.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['sepsis', 'Immunotherapy', 'Thymosin'], 'conditions': ['Severe Sepsis']}, 'referencesModule': {'references': [{'pmid': '23327199', 'type': 'DERIVED', 'citation': 'Wu J, Zhou L, Liu J, Ma G, Kou Q, He Z, Chen J, Ou-Yang B, Chen M, Li Y, Wu X, Gu B, Chen L, Zou Z, Qiang X, Chen Y, Lin A, Zhang G, Guan X. The efficacy of thymosin alpha 1 for severe sepsis (ETASS): a multicenter, single-blind, randomized and controlled trial. Crit Care. 2013 Jan 17;17(1):R8. doi: 10.1186/cc11932.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.', 'detailedDescription': 'Severe sepsis is a disease of infectious origin with a high risk of death. Over the past decade, thymosin alpha1 have already provided clinicians with additional weapon in the fight against infectious diseases, but it is unknown whether thymosin alpha1 is effective in treating severe sepsis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Severe sepsis according to ACCP/CCM criteria\n* Patient or legally authorized representative able to provide informed consent\n\nExclusion Criteria:\n\n* Subject is less than 18 years or more than 85 years of age\n* If female, the subject is pregnant or nursing\n* Subject is receiving immunosuppressive therapy such as cyclosporine, azothioprine,or cancer-related chemotherapy\n* Patient not expected to survive 28 days because of uncorrectable medical condition, such as poorly controlled neoplasm or other end-stage disease\n* History of bone marrow, lung, liver, pancreas, or small-bowel transplantation\n* Acute pancreatitis with no established source of infection'}, 'identificationModule': {'nctId': 'NCT00711620', 'acronym': 'ETASS', 'briefTitle': 'Efficacy of Thymosin alpha1 for Severe Sepsis', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis', 'orgStudyIdInfo': {'id': '2007015'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Thymosin alpha 1+Standard Therapy', 'description': 'Patients receive treatment based on SSC guideline with additional thymosin alpha1', 'interventionNames': ['Drug: Thymosin alpha 1']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'normal saline+standard therapy', 'description': 'Patients receive treatment based on SSC guideline with additional normal saline.', 'interventionNames': ['Drug: Thymosin alpha 1']}], 'interventions': [{'name': 'Thymosin alpha 1', 'type': 'DRUG', 'otherNames': ['Zadaxin'], 'description': '1.6 mg s.c injection twice per day for 5 days, then 1.6 mg s.c injection once per day for 2 days.', 'armGroupLabels': ['Thymosin alpha 1+Standard Therapy', 'normal saline+standard therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510080', 'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Sun Yat-sen University', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}], 'overallOfficials': [{'name': 'Guan Xiangdong, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Sun Yat-sen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Guan Xiangdong', 'oldOrganization': 'Sun Yat-sen University'}}}}