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Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ShenFeng, Eastern Hepatobiliary Surgery Hospital
ClinicalTrials.gov Identifier:
NCT01643447
First received: July 16, 2012
Last updated: March 30, 2016
Last verified: March 2016
  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:


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 ]

Enrollment: 200
Study Start Date: May 2012
Study Completion Date: April 2015
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   (Adult)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643447

Locations
China, Shanghai
Eastern Hepatobiliary Surgery Hospital
Shanghai, Shanghai, China
Sponsors and Collaborators
Eastern Hepatobiliary Surgery Hospital
Investigators
Study Chair: Li Aijun, MD Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
  More Information

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: March 30, 2016
Health Authority: China: Ministry of Health

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

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

ClinicalTrials.gov processed this record on September 23, 2016