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OpenTrials
Completed

NCT Number: NCT02829359

Effects of Antiviral Therapy on HBV Reactivation

Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA . The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA negative HBV-related HCC are unclear.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

About this study

Hepatitis B virus (HBV) reactivation happens after liver resection for HBV-related hepatocellular carcinoma (HCC) patients, particularly for those with positive serum HBV-DNA . The incidence rate and risk factors of HBV reactivation after hepatectomy for serum HBV-DNA negative HBV-related HCC are unclear.From July 2012 to December 2015, 174 consecutive patients with serum HBV-DNA negative HBV-related HCC underwent resection were prospectively enrolled in the studied. There are 66 patients received preoperative antiviral therapy (antiviral group) and 108 patients did not receive any antiviral therapy (non-antiviral group). The incidence of HBV reactivation, risk factors of liver function were analyzed in perioperative period. HBV reactivation developed in 30 patients (27.8%) in the non- antiviral group and 2 patients (3.0%) in the antiviral group, respectively (P < 0.001). Multivariate analysis revealed that minor hepatectomy (HR, 4.695; 95% CI, 1.257-17.537, P = 0.021) and without antiviral therapy (HR, 8.164; 95% CI, 1.831-36.397, p =0.006) were risk factors attributed to HBV reactivation. Patients in antiviral group and non-antiviral group or reactivation group and without reactivation group have similar ALT, TBil, ALB, and PT in 7 days after resection. However, patients in antiviral group have significantly better ALT and ALB on day 30th after resection than those in control group. Moreover, similar phenomenon were observed when comparing those with or without HBV reactivation. Resection could lead to HBV reactivation during the perioperative period for serum HBV DNA negative HBV-related HCC, especially in patients who did not receive any antiviral therapy. Anti-HBV therapy can reduce the risk of reactivation, thus improving liver function after hepatectomy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • underwent initial hepatectomy;
  • preoperative serum HBsAg positive
  • serum HBV DNA negative
  • serum ALT in normal range
  • Child-Pugh A liver function
  • HCC was confirmed by histopathology
  • patients in the treated group received Entecavir (ENT) while patients in the control group did not receive any antiviral therapy.

Exclusion criteria

  • underwent preoperative TACE or other anti-tumor treatments
  • underwent preoperative antiviral treatment for nearly a year
  • with autoimmune disease, other organ malignant tumor, or other severe disease.

Treatment and study plan

Entecavir therapy

Drug

Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month.

Primary outcomes

  1. Rate of HBV reactivation

    Time frame: 1 month after surgery

  2. HBV reactivation on the recovery of liver function

    Time frame: 1 month after surgery

Sponsors and collaborators

Lead sponsor

Guangxi Medical University

Other

Registry information

Official study title

Effects of Antiviral Therapy on HBV Reactivation and Liver Function After Hepatectomy for HBV-DNA Negative HBV-related Hepatocellular Carcinoma

Acronym: HBV-DNA(-)

Important dates

Study start
2012
Primary completion
2015
Study completion
2015
First posted
Jul 12, 2016
Registry last updated
Jun 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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