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
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