Clinical trial NCT02417207: Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation
Official title: Entecavir Combined Short-term Intravenous Hepatitis B Immune Globulin (HBIG) to Prevent Hepatitis B Recurrence After Liver Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B
Liver Transplantation
Keywords: hepatitis B immune globulin (HBIG)
liver transplantation
hepatitis B
entecavir
Lead sponsor: Third Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2015-04-15
Enrollment: 60
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: hepatitis B recurrence after liver transplantation
timeFrame: 2years
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Wang Guoying
state: Guangdong
Study officials:
affiliation: Third Affiliated Hospital, Sun Yat-Sen University
name: Yang Yang, MD
role: STUDY_CHAIR
References: