drugset / Trial / NCT02473406
Thymosin Alpha 1 in the Prevention of Pancreatic Infection Following Acute Necrotizing Pancreatitis
Phase 4
Completed
508 enrolled
Weiqin Li
908th Hospital of the Chinese People's Liberation Army Joint Logistic Support Force · collabClinical Medical College of Yangzhou University · collabJiangsu Province Hospital of Traditional Chinese Medicine · collabLuoyang Central Hospital · collabQilu Hospital of Shandong University · collabSecond Affiliated Hospital of Nantong University · collabThe Affiliated Hospital of Qingdao University · collabThe First Affiliated Hospital of Anhui Medical University · collabThe First Affiliated Hospital of Henan University of Science and Technology · collabThe First Affiliated Hospital of Nanchang University · collabThe First People's Hospital of Shangqiu · collabWannan Medical College Yijishan Hospital · collabZhejiang Provincial People's Hospital · collabZunyi Medical College · collabthe Affiliated Nanhua Hospital, University of South China · collab
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Infected pancreatic necrosis and its related septic complications are the major cause of death in patients with acute pancreatitis, therefore prevention of pancreatic infection is of great clinical value in the treatment of AP. Immunosuppression and disorders characterized by decreased HLA-DR expression and unbalanced CD3/CD4+/CD8+ T cells of PBMC are thought to be associated with the development of pancreatic infection. Thymosin alpha 1 has been shown to have immunomodulatory properties and its effects in preventing pancreatic infection was not well studied. To evaluate the effects of TA1 use in the early phase on preventing pancreatic infection, immunomodulation and clinical outcomes in patients with AP,we aimed to design this study.
Timeline
- Start
- 2018-03-27
- Primary completion
- 2020-12-24
- Completion
- 2021-03-24
Publications
- Huang X, Mao W, Hu X, Qin F, Zhao H, Zhang A, Wang X, Stoppe C, Zhou D, Ke L, Ni H; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Immune-Enhancing Treatment among Acute Necrotizing Pancreatitis Patients with Metabolic Abnormalities: A Post Hoc Analysis of a Randomized Clinical Trial. Gut Liver. 2024 Sep 15;18(5):906-914. doi: 10.5009/gnl230326. Epub 2024 Feb 15.
- Ke L, Mao W, Shao F, Zhou J, Xu M, Chen T, Liu Y, Tong Z, Windsor J, Ma P, Li W; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Association between pretreatment lymphocyte count and efficacy of immune-enhancing therapy in acute necrotising pancreatitis: a post-hoc analysis of the multicentre, randomised, placebo-controlled TRACE trial. EClinicalMedicine. 2023 Mar 24;58:101915. doi: 10.1016/j.eclinm.2023.101915. eCollection 2023 Apr.
- Zhou J, Mao W, Ke L, Chen T, He W, Pan X, Chen M, He C, Gu W, Wu J, Song J, Ni H, Tu J, Sun J, Zhang G, Chen W, Xue B, Zhao X, Shao M, Liu Y, Tong Z, Li W; Chinese Acute Pancreatitis Clinical Trials Group (CAPCTG). Thymosin alpha 1 in the prevention of infected pancreatic necrosis following acute necrotising pancreatitis (TRACE trial): protocol of a multicentre, randomised, double-blind, placebo-controlled, parallel-group trial. BMJ Open. 2020 Sep 29;10(9):e037231. doi: 10.1136/bmjopen-2020-037231.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Thymalfasin | Peptide | 1.6 mg | Subcutaneous |