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

Information source: Third Affiliated Hospital, Sun Yat-Sen University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hepatitis B; Liver Transplantation

Intervention: Entecavir combined long-term low-dose HBIG group intramuscular (Drug); Entecavir combined HBIG group short-term high-dose intravenous (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Third Affiliated Hospital, Sun Yat-Sen University

Official(s) and/or principal investigator(s):
Yang Yang, MD, Study Chair, Affiliation: Third Affiliated Hospital, Sun Yat-Sen University

Overall contact:
Wang Guoying, MD, Phone: 086-13632407313, Email: wanggy3@126.com

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 Details

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

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

Primary outcome: hepatitis B recurrence after liver transplantation

Detailed 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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria: 1. correlation disease hepatitis B viral hepatitis liver transplantation recipients for the first time; 2. older than 18 years old, men and women not limited; 3. preoperative HbsAg positive, regardless of whether preoperative HBV DNA level, regardless of whether preoperative antiviral treatment, regardless of whether associated with primary liver cancer; 4. donor HbsAg negative, other virology negative in liver conditions; 5. to integrate research, good adherence. Exclusion Criteria: 1. overlap other types of viral hepatitis; 2. the correlation of end-stage liver disease hepatitis b; 3. again to liver transplantation, or joint organ transplantation; 4. allergic to hepatitis b immune globulin; 5. of primary hepatocellular carcinoma with vena cava, portal vein around the trunk or branch, hepatic vein and other large vascular invasion; 6. ABO blood group incompatibility in liver transplantation; 7. moderately severe renal insufficiency, serum creatinine 180 umol/L or higher; 8. there has been a drug resistance of entecavir before liver transplantation.

Locations and Contacts

Wang Guoying, MD, Phone: 086-13632407313, Email: wanggy3@126.com

Wang Guoying, Guangzhou, Guangdong 510630, China
Additional Information

Starting date: April 2015
Last updated: April 10, 2015

Page last updated: August 23, 2015

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