A randomized controlled trial to study whether telbivudine can prevent virus reactivation and improve the prognosis after liver resection in patients with hepatitis B virus-related hepatocellular carcinoma

Phase 4

Active, not recruiting

• Conditions: hepatitis B virus-related hepatocellulcar carcinoma; Infection - Other infectious diseases; Cancer - Liver; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12614001224617
• Lead Sponsor: ZHOU Wei-ping

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-11-21
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1) Age 18 to 70 years;
2) Positive test for Hepatitis B surface antigen (HBsAg)
3) Serum hepatitis B virus-deoxyribonucleic acid (HBV-DNA) level lower than 2000IU/ml;
4) Serum ALT levels are below the upper limit of normal (ULN);
5) Resectable tumour with Barcelona Clinic Liver Cancer (BCLA) stage 0 or A;
6)Good liver function with Child-Pugh Class A, with no history of encephalopathy, ascites refractory to diuretics, esophago-gastricvaricesor variceal bleeding;
7) Good kidney function (a serum creatinine level < 133 umol/L and creatinine clearance >60 ml/min);
8) The preoperative diagnosis of HCC was based on the diagnostic criteria for HCC used by the European Association for the Study of the Liver (EASL).

Exclusion Criteria

1)Positive tests for antibody to hepatitis C virus (HCV-Ab) or human immunodeficiency virus;
2)extrahepatic metastasis;
3)radiologic evidence of invasion into the major portal/hepatic venous branches;
4)previous treatment of HCC;
5)previous history of antiviral therapy;
6)previous history of cancer and chemotherapy
7)previous history of immunosuppressive therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary outcome is the postoperative hepatitis B virus reactivation rates. The copy of HBV-DNA in the blood will be detected 1 month after surgery and then every 3 month. When the HBV-DNA is 10-fold higher or from undectable to be detectable, it is defined as virus reactivation.[the time when the hepatitis B virus is reactiveted or the time when the follow-up is ceased (at least 3 years follow-up)]

Secondary Outcome Measures

Name	Time	Method
overall survival[paeticipants will be followed up to 3 years post operation or the time when patients died.]