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

NCT02417207 | Unknown Phase 4 DMC

• 1 other identifier: (2014)2-127
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis B; Liver Transplantation

Keywords

hepatitis B immune globulin (HBIG); liver transplantation; hepatitis B; entecavir

Outcome Measures

Primary Outcomes (1)

• hepatitis B recurrence after liver transplantation

  2years

Study Arms (2)

Entecavir combined long-term low-dose HBIG group intramuscular

SHAM COMPARATOR

HBIG scheme is: the use of intraoperative muscle injection of 800 IU HBIG, postoperative week 1 intramuscular injection HBIG 400 IU 1 times a day, 1 week after intramuscular injection HBIG 400 IU 2 times per week, dosage and time interval according to the HBsAb drops in patients with degree of level adjustment, target drops for 3 months or more after 500 IU/mL, 3 \~ 6 months or 300 IU/mL, after six months of 100 IU/mL or more.

Drug: Entecavir combined long-term low-dose HBIG group intramuscular

Entecavir combined HBIG group short-term high-dose intravenous

ACTIVE COMPARATOR

Preoperative HBV DNA level is less than 1000 IU/ml, intraoperative intravenous drip of 2500 IU HBIG static note type, postoperative 1 and 15 days respectively to give 2500 IU HBIG static note type, a total of three times, then no longer apply. Preoperative HBV DNA level greater than 1000 IU/ml, the use of HBIG solution for: intraoperative intravenous drip of 5000 IU HBIG static note type, postoperative day 1, 15 days and 30 days respectively to give 2000-2500 IU HBIG static note type, a total of four times, since then no longer apply. Preoperative HBV DNA level of the unknown, preoperative immediate detection of DNA, intraoperative intravenous drip of 5000 iu HBIG static note type, choose according to test results after dosing frequency.

Drug: Entecavir combined HBIG group short-term high-dose intravenous

Interventions

Entecavir combined long-term low-dose HBIG group intramuscular DRUG

HBIG scheme is: the use of intraoperative muscle injection of 800 IU HBIG, postoperative week 1 intramuscular injection HBIG 400 IU 1 times a day, 1 week after intramuscular injection HBIG 400 IU 2 times per week, dosage and time interval according to the HBsAb drops in patients with degree of level adjustment, target drops for 3 months or more after 500 IU/mL, 3 \~ 6 months or 300 IU/mL, after six months of 100 IU/mL or more.

Entecavir combined long-term low-dose HBIG group intramuscular

Entecavir combined HBIG group short-term high-dose intravenous DRUG

Preoperative HBV DNA level is less than 1000 IU/ml, intraoperative intravenous drip of 2500 IU HBIG static note type, postoperative 1 and 15 days respectively to give 2500 IU HBIG static note type, a total of three times, then no longer apply. Preoperative HBV DNA level greater than 1000 IU/ml, the use of HBIG solution for: intraoperative intravenous drip of 5000 IU HBIG static note type, postoperative day 1, 15 days and 30 days respectively to give 2000-2500 IU HBIG static note type, a total of four times, since then no longer apply. Preoperative HBV DNA level of the unknown, preoperative immediate detection of DNA, intraoperative intravenous drip of 5000 iu HBIG static note type, choose according to test results after dosing frequency.

Entecavir combined HBIG group short-term high-dose intravenous

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• correlation disease hepatitis B viral hepatitis liver transplantation recipients for the first time;
• older than 18 years old, men and women not limited;
• preoperative HbsAg positive, regardless of whether preoperative HBV DNA level, regardless of whether preoperative antiviral treatment, regardless of whether associated with primary liver cancer;
• donor HbsAg negative, other virology negative in liver conditions;
• to integrate research, good adherence.

You may not qualify if:

• overlap other types of viral hepatitis;
• the correlation of end-stage liver disease hepatitis b;
• again to liver transplantation, or joint organ transplantation;
• allergic to hepatitis b immune globulin;
• of primary hepatocellular carcinoma with vena cava, portal vein around the trunk or branch, hepatic vein and other large vascular invasion;
• ABO blood group incompatibility in liver transplantation;
• moderately severe renal insufficiency, serum creatinine 180 umol/L or higher;
• there has been a drug resistance of entecavir before liver transplantation.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Wang Guoying

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Yang Yang, MD

  Third Affiliated Hospital, Sun Yat-Sen University

  STUDY CHAIR

Central Study Contacts

Wang Guoying, MD

CONTACT

086-13632407313; wanggy3@126.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 7, 2015
• First Posted: April 15, 2015
• Study Start: April 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

CN (1)