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Sponsored by: |
Sun Yat-sen University |
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Information provided by: | Sun Yat-sen University |
ClinicalTrials.gov Identifier: | NCT00711620 |
The purpose of this study is to evaluate the efficacy of thymosin alpha 1 for treating severe sepsis.
Condition | Intervention |
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Severe Sepsis |
Drug: Thymosin alpha 1 |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Parallel Assignment, Efficacy Study |
Official Title: | Multicenter, Randomized, Controlled Study to Evaluate the Efficacy of Thymosin alpha1 in Patients With Severe Sepsis |
Estimated Enrollment: | 334 |
Study Start Date: | May 2008 |
Estimated Study Completion Date: | January 2010 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Experimental
Patients receive treatment based on SSC guideline with additional thymosin alpha1.
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Drug: Thymosin alpha 1
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.
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B: No Intervention
Patients receive treatment based on SSC guideline.
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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.
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Guan Xiangdong, M.D | 020-87755766 ext 8456 | carlg@163.com |
Contact: Wu Jianfeng, M.D | 020-87755766 ext 8454 | wujianfeng9571@163.com |
China, Guangdong | |
Sun Yat-sen University | Recruiting |
Guangzhou, Guangdong, China, 510080 | |
Contact: Wu Jianfeng, M.D 020-87755766 ext 8454 wujiafeng9571@163.com | |
Contact: Guan Xiangdong, M.D 020-87755766 ext 8456 carlg@163.com | |
Principal Investigator: Guan Xiangdong, M.D | |
Sub-Investigator: Wu Jianfeng, M.D |
Study Chair: | Guan Xiangdong, M.D | Sun Yat-sen University |
Responsible Party: | Sun Yat-sen University ( Guan Xiangdong ) |
Study ID Numbers: | 2007015 |
Study First Received: | June 27, 2008 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00711620 History of Changes |
Health Authority: | China: Ministry of Health |
sepsis Immunotherapy Thymosin |
Systemic Inflammatory Response Syndrome Sepsis Thymalfasin |
Immunologic Factors Adjuvants, Immunologic Inflammation |
Systemic Inflammatory Response Syndrome Sepsis Thymalfasin Pathologic Processes Immunologic Factors Antineoplastic Agents |
Therapeutic Uses Physiological Effects of Drugs Adjuvants, Immunologic Infection Pharmacologic Actions Inflammation |