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Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)

This study is currently recruiting participants.
Verified July 2012 by Eastern Hepatobiliary Surgery Hospital
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT01643447
First received: July 16, 2012
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  Purpose

The purpose of this study is to confirm that Ulinastatin is a safe and effective drug and it can reduce the incidence of postoperative hepatic failure in HCC patients. To evaluate that Ulinastatin can improve survival in HCC patients or not.


Condition Intervention
Hepatocellular Carcinoma
 Drug: Ulinastatin
Drug: Diammonium glycyrrhizinate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomized Trial Comparing Ulinastatin's Drug Protection in Hepatocellular Carcinoma(HCC)Patients'Postoperative Hepatic Failure

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Eastern Hepatobiliary Surgery Hospital:

Primary Outcome Measures:
  • the overall survival rate of each group [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diammonium glycyrrhizinate
Conventional drugs protect liver
 Drug: Diammonium glycyrrhizinate
Experimental: Ulinastatin
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
 Drug: Ulinastatin
Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)

Detailed Description:

Hepatocellular carcinoma (HCC), a serious disease with high incidence at home and abroad, still shows a rising trend. Postoperative hepatic failure remains a major reason of liver resection's failure.

• As broad spectrum of enzyme inhibitors, Ulinastatin has the valid therapeutical effect of hepatic failure and hepatic ischemia-reperfusion injury in animal experiment. And it restrain inflammatory mediator to release. But it's lack of clinical evidence that Ulinastatin reduce the incidence of postoperative hepatic failure in HCC patients The purpose of the study is to assess the effort for comparing Ulinastatin's drug protection in patients with hepatocellular carcinoma (HCC) for postoperative hepatic failure and to evaluate that Ulinastatin can improve survival in HCC patients or not.

  Eligibility

Ages Eligible for Study:   35 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients > 35 years and <=55 years of age.
  2. confirmed case (patients with HCC)
  3. Tumors can be radical removed and resection volume was 50% to 70%.
  4. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  5. No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
  6. Karnofsky Performance Score performance over 60.
  7. Patients who can understand this trial and have signed information consent.

Exclusion Criteria:

  1. Patients who have undergone previous treatment by Ulinastatin.
  2. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
  3. Patients with other diseases which may affect the treatment mentioned here.
  4. Patients with medical history of other malignant tumors.
  5. Subjects participating in other clinical trials.
  6. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
  7. Patients would not sign the consent to the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01643447

Contacts
Contact: Li Aijun, MD 86-21-81875531 ajli62@gmail.com
Contact: Yuan Hang, DOCTOR 86-21-81875531 hamiltonbill83@gmail.com

Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital Recruiting
Shanghai, Shanghai, China
Contact: LI Aijun, MD     86-21-81875531     ajli62@gmail.com    
Contact: Yuan Hang, DOCTOR     86-21-81875531     hamiltonbill83@gmail.com    
Principal Investigator: Li Aijun, MD            
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Li Aijun, MD Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  More Information

No publications provided

Responsible Party: ShenFeng, director of department of special treatment, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier: NCT01643447     History of Changes
Other Study ID Numbers: EHBH-RCT-2012-001
Study First Received: July 16, 2012
Last Updated: July 17, 2012
Health Authority: China: Ministry of Health

Keywords provided by Eastern Hepatobiliary Surgery Hospital:
Hepatocellular Carcinoma
Ulinastatin
Hepatic Failure

Additional relevant MeSH terms:
Carcinoma
Liver Failure
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Glycyrrhizic Acid
Urinastatin
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 16, 2013