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

A randomized clinical trial to study whether telbivudine can decrease the hepatitis B virus reactivation in patients with hepatocellular carcinoma and HBV-DNA < 2000 IU/ml after liver resection.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614001224617

Enrollment

200

Registered

2014-11-21

Start date

2012-04-18

Completion date

2014-10-28

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The primary purpose of our study was to see whether preemptive telbivudine treatment in HCC patients with HBV DNA <2000 IU/ml could prevent postoperative HBV reactivation.

Interventions

Patients in the telbivudine group received telbivudine 600 mg orally, once a day. The treatment will begin within 1 week after liver resection and last for 1 year. The patient will be monitored by regular laboratory test and follow-up call.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 70 Years

Healthy volunteers

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

Outcome results