Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation

Hepatitis B Clinical Trial

Official title: Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation

Status Not yet recruiting

Clinical Trial Summary

The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence.

Clinical Trial Description

At present, the prevention of hepatitis B recurrence after liver transplantation is the most commonly used scheme for nucleoside analogue combined hepatitis B immune globulin (HBIG). HBIG is a condensed to prevent the efficient price of invasion of hepatitis b immunoglobulin, its function is a direct and virus.Also it is to block the virus into liver cells. Lamivudine with HBIG therapy has hepatitis b recurrence rate reduced to below 10%, entecavir combined HBIG hepatitis b recurrence rate is low below 1%. In European and American countries, HBIG the most commonly used method for long-term high-dose intravenous drip, but our country is long-term low-dose intramuscular injection, but all need lifelong medication, for how long after surgery or which patients can disable or not HBIG no consensus. Whether long-term intravenous drip or intramuscular HBIG, are some disadvantages such as high cost, drug side effects, also brought inconvenience to patients. The advent of potent against hepatitis b virus drugs continuously under the background of, in recent years, scholars have already begun to no application or short-term application HBIG discontinuation to prevent hepatitis b recurrence after research, low before transplantation of hepatitis B virus(HBV) DNA replication, such as effective antiviral therapy of hepatitis b recurrence after after transplantation were created the conditions of no HBIG solution. Most studies suggest that transplantation of nucleoside analogues alone for a long time without application or short-term application of HBIG scheme to prevent hepatitis b recurrence is safe, but there are only several transplant center in study abroad, and the Chinese mainland for all application or short-term application of HBIG clinical studies. Entecavir with potent antiviral capacity and high genetic barrier to resistance, low incidence of drug resistance, is currently the prevention and treatment of hepatitis b recurrence after liver transplantation of first-line drugs, entecavir combined long-term muscle injection low-dose HBIG is at present our country is the most commonly used drug for liver transplantation in our center.

This study for entecavir combined after liver transplantation for short-term application type static note HBIG to prevent hepatitis b recurrence of prospective, multicenter, randomized, controlled experimental study, the equivalence. The purpose of this study is to observe a new scheme can achieve is the same as the traditional scheme of the effect of preventing hepatitis B recurrence. ;

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Liver Transplantation

• NCT number: NCT02417207
• Study type: Interventional
• Source: Third Affiliated Hospital, Sun Yat-Sen University
• Contact: Wang Guoying, MD
• Phone: 086-13632407313
• Email: wanggy3@126.com
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 2015
• Completion date: April 2018