Effects of Antiviral Therapy on HBV Reactivation

NCT02829359 | Completed Phase 2 DMC

• 1 other identifier: HBV-DNA(-)/HCC
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Liver Cancer

Outcome Measures

Primary Outcomes (2)

• Rate of HBV reactivation

  1 month after surgery

• HBV reactivation on the recovery of liver function

  1 month after surgery

Study Arms (2)

Entecavir therapy

EXPERIMENTAL

Patients who received entecavir (zhengda Tianqing Co., Ltd, Lianyungang, Jiangsu Province, China; 0.5 mg/d) were submitted to antiviral group. Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month. No immunological therapy in perioperative period will be submitted to any included patients.

Drug: Entecavir therapy

No antiviral therapy

NO INTERVENTION

Patients who did not receive any antiviral therapies were submitted as non-antiviral group. Patients in the non-antiviral group who underwent HBV reactivation will receive entecavir therapy. No immunological therapy in perioperative period will be submitted to any included patients.

Interventions

Entecavir therapy DRUG

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

Entecavir therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Guangxi Medical University: lead

Related Publications (7)

• Li X, Zhong X, Chen ZH, Wang TT, Ma XK, Xing YF, Wu DH, Dong M, Chen J, Ruan DY, Lin ZX, Wen JY, Wei L, Wu XY, Lin Q. Efficacy of Prophylactic Entecavir for Hepatitis B Virus-Related Hepatocellular Carcinoma Receiving Transcatheter Arterial Chemoembolization. Asian Pac J Cancer Prev. 2015;16(18):8665-70. doi: 10.7314/apjcp.2015.16.18.8665.

  PMID: 26745134 BACKGROUND

• Xie ZB, Zhu SL, Peng YC, Chen J, Wang XB, Ma L, Bai T, Xiang BD, Li LQ, Zhong JH. Postoperative hepatitis B virus reactivation and surgery-induced immunosuppression in patients with hepatitis B-related hepatocellular carcinoma. J Surg Oncol. 2015 Nov;112(6):634-42. doi: 10.1002/jso.24044. Epub 2015 Sep 30.

  PMID: 26421419 BACKGROUND

• Jang JW, Kim YW, Lee SW, Kwon JH, Nam SW, Bae SH, Choi JY, Yoon SK, Chung KW. Reactivation of hepatitis B virus in HBsAg-negative patients with hepatocellular carcinoma. PLoS One. 2015 Apr 20;10(3):e0122041. doi: 10.1371/journal.pone.0122041. eCollection 2015.

  PMID: 25894607 BACKGROUND

• Sohn W, Paik YH, Cho JY, Ahn JM, Choi GS, Kim JM, Kwon CH, Joh JW, Sinn DH, Gwak GY, Choi MS, Lee JH, Koh KC, Paik SW, Yoo BC. Influence of hepatitis B virus reactivation on the recurrence of HBV-related hepatocellular carcinoma after curative resection in patients with low viral load. J Viral Hepat. 2015 Jun;22(6):539-50. doi: 10.1111/jvh.12356. Epub 2014 Nov 7.

  PMID: 25377516 BACKGROUND

• Lee JI, Kim JK, Chang HY, Lee JW, Kim JM, Chung HJ, Kim YS, Lee KS. Impact of postoperative hepatitis B virus reactivation in hepatocellular carcinoma patients who formerly had naturally suppressed virus. J Gastroenterol Hepatol. 2014 May;29(5):1019-27. doi: 10.1111/jgh.12472.

  PMID: 24325315 BACKGROUND

• Huang L, Li J, Yan J, Sun J, Zhang X, Wu M, Yan Y. Antiviral therapy decreases viral reactivation in patients with hepatitis B virus-related hepatocellular carcinoma undergoing hepatectomy: a randomized controlled trial. J Viral Hepat. 2013 May;20(5):336-42. doi: 10.1111/jvh.12036. Epub 2012 Dec 5.

  PMID: 23565616 BACKGROUND

• Lao XM, Luo G, Ye LT, Luo C, Shi M, Wang D, Guo R, Chen M, Li S, Lin X, Yuan Y. Effects of antiviral therapy on hepatitis B virus reactivation and liver function after resection or chemoembolization for hepatocellular carcinoma. Liver Int. 2013 Apr;33(4):595-604. doi: 10.1111/liv.12112. Epub 2013 Feb 13.

  PMID: 23402625 BACKGROUND

MeSH Terms

Conditions

Liver Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• Le-Qun Li, MD

  Cancer Hospital of Guangxi Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Affiliated Tumor Hospital of Guangxi Medical University

Study Record Dates

• First Submitted: July 8, 2016
• First Posted: July 12, 2016
• Study Start: July 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 12, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share