Life sciences · Phase 4 Trial
ClinicalTrials.gov · November 6, 2026
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Phase 4 Trial.
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Registry record from ClinicalTrials.gov (NCT07922954). This is a study registration, not published results. Lead sponsor: Southeast University, China. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: PHASE4. Study type: INTERVENTIONAL. Enrollment: 36 participants (ESTIMATED). Conditions: Sepsis, Septic Shock. Interventions: DRUG: Thymalfasin. Primary outcome measures: Serum IgM Concentration , Baseline and days 1, 3, 5, and 7 after treatment. Brief summary: This prospective, single-arm study will evaluate whether thymosin alpha 1 treatment affects serum immunoglobulin M (IgM) levels in adults with sepsis. Participants will receive standard care plus thymosin alpha 1 1.6 mg by subcutaneous injection every 12 hours for 5 days. Blood samples will be collected before treatment and on days 1, 3, 5, and 7 to measure IgM and plasma microvesicles. The study aims to clarify whether thymosin alpha 1 may support early immune responses in sepsis.