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

NCT02417207 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-04-15

No results posted yet for this study

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

Interventions

DRUG

Entecavir combined long-term low-dose HBIG group intramuscular

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 HBIG group short-term high-dose intravenous

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.

Sponsors & Collaborators

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Yang Yang, MD · Third Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2018-04-30
Completion
2018-04-30

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02417207 on ClinicalTrials.gov