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ActivePhase 4ACTRN12614001224617

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.

Sponsor

ZHOU Wei-ping

Enrollment

200 participants

Start Date

Apr 18, 2012

Study Type

Interventional

Conditions

hepatitis B virus-related hepatocellulcar carcinoma

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.

Eligibility

Sex: Both males and femalesMin Age: 18 YearssMax Age: 70 Yearss

Inclusion Criteria8

  • Age 18 to 70 years;
  • Positive test for Hepatitis B surface antigen (HBsAg)
  • Serum hepatitis B virus-deoxyribonucleic acid (HBV-DNA) level lower than 2000IU/ml;
  • Serum ALT levels are below the upper limit of normal (ULN);
  • Resectable tumour with Barcelona Clinic Liver Cancer (BCLA) stage 0 or A;
  • Good liver function with Child-Pugh Class A, with no history of encephalopathy, ascites refractory to diuretics, esophago-gastricvaricesor variceal bleeding;
  • Good kidney function (a serum creatinine level < 133 umol/L and creatinine clearance >60 ml/min);
  • 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 Criteria7

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

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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 reg

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.

Locations(1)

Shanghai, China

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ACTRN12614001224617