Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular Carcinoma (HCC)

NCT01643447 | Completed DMC

• 1 other identifier: EHBH-RCT-2012-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular Carcinoma; Ulinastatin; Hepatic Failure

Outcome Measures

Primary Outcomes (1)

• the overall survival rate of each group

  3 years

Study Arms (2)

Diammonium glycyrrhizinate

ACTIVE COMPARATOR

Conventional drugs protect liver

Drug: Diammonium glycyrrhizinate

Ulinastatin

EXPERIMENTAL

Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)

Drug: Ulinastatin

Interventions

Ulinastatin DRUG

Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)

Ulinastatin

Diammonium glycyrrhizinate DRUG

Diammonium glycyrrhizinate

Eligibility Criteria

• Age: 35 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female patients \> 35 years and \<=55 years of age.
• confirmed case (patients with HCC)
• Tumors can be radical removed and resection volume was 50% to 70%.
• 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.
• 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.
• Karnofsky Performance Score performance over 60.
• Patients who can understand this trial and have signed information consent.

You may not qualify if:

• Patients who have undergone previous treatment by Ulinastatin.
• Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
• Patients with other diseases which may affect the treatment mentioned here.
• Patients with medical history of other malignant tumors.
• Subjects participating in other clinical trials.
• Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
• Patients would not sign the consent to the trial.

Sponsors & Collaborators

• Eastern Hepatobiliary Surgery Hospital: lead

Study Sites (1)

Eastern Hepatobiliary Surgery Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Failure

Interventions

urinastatin; Glycyrrhizic Acid

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases; Hepatic Insufficiency

Intervention Hierarchy (Ancestors)

Pentacyclic Triterpenes; Triterpenes; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Li Aijun, MD

  Eastern Hepatobiliary Surgery Hospital, Second Military Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director of department of special treatment

Study Record Dates

• First Submitted: July 16, 2012
• First Posted: July 18, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: April 1, 2015
• Last Updated: March 31, 2016

Record last verified: 2016-03

Locations

CN (1)