drugset / Trial / NCT01132521
Ulinastatin in Severe Acute Pancreatitis
Phase 4
Suspended
252 enrolled
Techpool Bio-Pharma Co., Ltd.
First Affiliated Hospital, Sun Yat-Sen University · collabPeking Union Medical College Hospital · collabThe First Affiliated Hospital with Nanjing Medical University · collabThe first clinical college of harbin medical university · collabUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology · collabWest China Hospital · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
This study aims to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis.
Timeline
- Start
- 2010-06
- Primary completion
- 2018-12
- Completion
- 2018-12
Outcome
Met primary endpoint
Stopped: “Revised project”
paper Six patients in the ulinastatin group and 15 patients in the placebo group developed pancreatitis (2.9% vs. 7.4%, P = .041). PMID 15822043 ↗
Publications
- Results Wang CY, Zhao YP. Progress of therapeutic effect in severe acute pancreatitis: Mini-review of treatment viewpoints and technique improvements. Chin J Surg 44(13): 872-4, 2006. (Article in Chinese)
- Results Maehara K, Kanayama N, Halim A, el Maradny E, Oda T, Fujita M, Terao T. Down-regulation of interleukin-8 gene expression in HL60 cell line by human Kunitz-type trypsin inhibitor. Biochem Biophys Res Commun. 1995 Jan 26;206(3):927-34. doi: 10.1006/bbrc.1995.1131.
- Results Tsujino T, Komatsu Y, Isayama H, Hirano K, Sasahira N, Yamamoto N, Toda N, Ito Y, Nakai Y, Tada M, Matsumura M, Yoshida H, Kawabe T, Shiratori Y, Omata M. Ulinastatin for pancreatitis after endoscopic retrograde cholangiopancreatography: a randomized, controlled trial. Clin Gastroenterol Hepatol. 2005 Apr;3(4):376-83. doi: 10.1016/s1542-3565(04)00671-8.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Ulinastatin | Protein / enzyme biologic | — | Intravenous |