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A randomized controlled trial:Evaluating the impact of telbivudine treatment on the prognosis of HBV-related liver cancer and posthepatectomy HBV reactivation in hepatitis B-related hepatocellular carcinoma.

A randomized controlled trial:Evaluating the impact of telbivudine treatment on the prognosis of HBV-related liver cancer and posthepatectomy HBV reactivation in hepatitis B-related hepatocellular carcinoma.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IPR-15006587
Enrollment
Unknown
Registered
2015-05-26
Start date
2008-11-01
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

hepatitis B-related hepatocellular carcinoma

Interventions

Sponsors

Eastern Hepatobiliary Surgical hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. age 18 to 70 years; 2. positive test for Hepatitis B surface antigen (HBsAg) and negative test for antibody to hepatitis C virus (HCV-Ab) or human immunodeficiency virus; 3. serum hepatitis B virus-deoxyribonucleic acid (HBV-DNA) level lower than 2000 IU/ml; 4. Barcelona Clinic Liver Cancer (BCLA) stage 0, A or a solitary tumor with diameter> 5cm; 5. no extrahepatic metastasis; 6. no radiologic evidence of invasion into major portal/hepatic venous branches; 7. good liver function with Child - Pugh Class A and baseline serum alanine aminotransferase (ALT) level< 2 times the upper limit of normal (reference range<40 IU/L), with no history of encephalopathy, ascites refractory to diuretics, esophago-gastric variceal bleeding; 8. good renal function(a serum creatinine level < 133 umol/L); 9. no previous treatment for hepatitis B with nucleoside or nucleotide analogues or both; 10. no treatment with interferon or other immunomodulators within the previous 12 months; 11. a serum amylase or lipase level lower than 1.5 times the upper limit of normal; 12. no previous treatment of HCC; 13. negative resection margin (R0 resection); 14. histopathological result of the resected specimens being HCC. Eligible patients were excluded if they refused to participate.

Exclusion criteria

Exclusion criteria: patients were excluded if they refused to participate or they are not eligible.

Design outcomes

Primary

MeasureTime frame
rate of HBV reactivationon;Rate of tumor recurrence;survival rate;

Countries

CHina

Contacts

Public ContactWeiping Zhou
ehphwp@126.com+86 13601616763

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 21, 2026