Ulinastatin in Severe Acute Pancreatitis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Techpool Bio-Pharma Co., Ltd..
Recruitment status was  Recruiting
Sponsor:
Collaborators:
Peking Union Medical College Hospital
Wuhan Union Hospital, China
The First Clinical College of Harbin University
Jiangsu Province Hospital
West China Hospital
First Affiliated Hospital, Sun Yat-Sen University
Ruijing Hospital of Shanghai Jiaotong University
Information provided by:
Techpool Bio-Pharma Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01132521
First received: May 26, 2010
Last updated: October 12, 2010
Last verified: October 2010
  Purpose

This study aims to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis.


Condition Intervention Phase
Pancreatitis
Drug: ulinastatin
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Multicenter, Double-bind, Randomised, Placebo Controlled Study of Ulinastatin in Severe Acute Pancreatitis

Resource links provided by NLM:


Further study details as provided by Techpool Bio-Pharma Co., Ltd.:

Primary Outcome Measures:
  • multiple organ dysfunction score [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • onset of (multiple) organ failure after randomized [ Time Frame: 8 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality [ Time Frame: 8 days, 14 days and 28 days ] [ Designated as safety issue: No ]
  • Incidence of complications [ Time Frame: 8 days, 14 days and 28 days ] [ Designated as safety issue: No ]
  • APACHE Ⅱ score [ Time Frame: 8 days ] [ Designated as safety issue: No ]
  • Need for surgical intervention [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
  • Hospital stay and ICU stay [ Time Frame: From admission to discharge ] [ Designated as safety issue: No ]
  • CT-scan score [ Time Frame: 8 days, 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: June 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ulinastatin group
Regular treatments plus ulinastatin. Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
Drug: ulinastatin
Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
Other Names:
  • UTI
  • urinary trypsin inhibitor
  • bikunin
Placebo Comparator: placebo group
Regular treatment plus placebo. Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
Drug: placebo
Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.

Detailed Description:

About 20% of patients with acute pancreatitis have a severe course, and 10-15% of those with severe acute pancreatitis (SAP) die. Despite improvements in intensive care treatment during past few decades, effective therapies for acute pancreatitis are still limited.

Early deaths (within the first week) due to severe acute pancreatitis are generally caused by massive inflammatory responses which result in multiple organ failure. Although the exact mechanisms which trigger the inflammatory processes are not completely understood, it is generally accepted that autodigestion and activated leukocytes play important roles in the pathogenesis of acute pancreatitis. Activation of digestive enzymes causes pancreatic injury and results in an inflammatory response that is out of proportion to the response of other organs to a similar insult. The acute inflammatory response itself causes substantial tissue damage and may progress beyond the pancreas to a systemic inflammatory response syndrome, multi organ failure, or death.

UTI is a multivalent Kunitz-type serine protease inhibitor that is found in human urine and blood, it can stabilize lysosome membrane and inhibit lysosome function, inhibit the various enzymes and inflammatory response. Previous study proved that it protects against SIRS pathophysiology and subsequent organ damage induced via the modulation of the proinflammatory mediator, as well as chemokines. UTI has been widely used for the treatment and prevention of multiple organ failure in China, but there is few randomized, placebo controlled trial on ulinastatin. A large multicenter, randomized study is warranted. In this study, we aim to evaluate the effect of ulinastatin in the treatment and prevention of organ failure in severe acute pancreatitis with regular treatment in an add-on trial.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of severe acute pancreatitis , severe acute pancreatitis adapted from the Atlanta classification:

Early Prognostic Signs: Ramson signs ≥3, APACHE II score ≥8 Organ Failure and/or Local Complications: Necrosis, Abscess, Pseudocyst;

  • Admission within 72h after onset of symptoms of pancreatitis
  • 18-70 years old
  • Signed the informed consent form

Exclusion Criteria:

  • Pre-existing chronic renal insufficiency requiring hemodialysis or peritoneal dialysis
  • pre existing heart dysfunction or NYHA classification score above III
  • pregnancy or lactation
  • Allergy for ulinastatin
  • Received an investigational drug or device within 90 days prior to entering study
  • serious mentally-ill patients including dementia
  • On the verge of death (estimated to be mortal in 12h).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01132521

Locations
China, Guangdong
The First Affiliated Hospital of Sun Yat-Sen University Recruiting
Guangzhou, Guangdong, China
Contact: Xiangdong Guan, MD       carlg@163.com   
Principal Investigator: Xiangdong Guan, MD         
China, Heilongjiang
The First Clinical College of Harbin University Recruiting
Harbin, Heilongjiang, China
Contact: Hongchi Jiang, MD       Jianghc@public.hr.hl.cn   
Contact: Bei Sun, MD       Sunbei70@tom.com   
Principal Investigator: Hongchi Jiang, MD         
Principal Investigator: Bei Sun, MD         
China, Hubei
Wuhan Union Hospital of China Recruiting
Wuhan, Hubei, China
Contact: Chunyou Wang, MD       Chunyouwang52@126.com   
Contact: Zhiyong Yang, MD       dryzy@163.com   
Principal Investigator: Chunyou Wang, MD         
Sub-Investigator: Zhiyong Yang, MD         
China, Jiangsu
Jiangsu Province Hospital Recruiting
Nanjing, Jiangsu, China
Contact: Yi Miao, MD       Miaoyi@njum.edu.cn   
Contact: Qiang Li       liqiang020202@163.com   
Principal Investigator: Yi Miao, MD         
Sub-Investigator: Qiang Li, MD         
China, Sichun
West China Hospital Recruiting
Chengdu, Sichun, China
Contact: Xubao Liu, MD       xbliu@medmail.com.cn   
Contact: Gang Mai       maigang68@hotmail.com   
Principal Investigator: Xubao Liu, MD         
Sub-Investigator: Gang Mai, MD         
China
Peking Union Medical College Hospital Recruiting
Beijing, China
Contact: Yupei Zhao, MD       Zhao8028@263.net   
Contact: Dawei Liu, MD       dwliu98@yahoo.com   
Principal Investigator: Yupei Zhao, MD         
Principal Investigator: Dawei Liu, MD         
Sponsors and Collaborators
Techpool Bio-Pharma Co., Ltd.
Peking Union Medical College Hospital
Wuhan Union Hospital, China
The First Clinical College of Harbin University
Jiangsu Province Hospital
West China Hospital
First Affiliated Hospital, Sun Yat-Sen University
Ruijing Hospital of Shanghai Jiaotong University
Investigators
Study Chair: Yupei Zhao, MD Peking Union Medical College Hospital
Principal Investigator: Chunyou Wang, MD Wuhan Union Hospital, China
  More Information

Additional Information:
Publications:
Responsible Party: Chunya Zou, Techpool Bio-Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT01132521     History of Changes
Other Study ID Numbers: UTI/SAP-S
Study First Received: May 26, 2010
Last Updated: October 12, 2010
Health Authority: China: Ethics Committee

Keywords provided by Techpool Bio-Pharma Co., Ltd.:
ulinastatin
severe acute pancreatitis

Additional relevant MeSH terms:
Pancreatitis
Pancreatic Diseases
Digestive System Diseases
Trypsin Inhibitors
Urinastatin
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 14, 2014