Safety and Efficacy of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B (CHB)

Overview

Antiviral treatment on Chronic Hepatitis B (CHB) patients with liver cirrhosis is compulsory and effective. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Full Title of Study: “Clinical Study of Telbivudine on Liver Cirrhosis in Patients With Chronic Hepatitis B”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 2012

Detailed Description

Antiviral therapy on CHB patients with liver cirrhosis is compulsory and effective. Diseases development can be prevented or delayed if the virus is depressed successfully. Lamivudine is often used and usually has good efficacy. However, lamivudine resistance and virus mutation happens a lot. Telbivudine, which is superior to lamivudine in the treatment of CHB,is considered to be appropriate for the antiviral treatment on CHB patients with liver cirrhosis.

Interventions

  • Drug: telbivudine
    • telbivudine 600mg/d 96 weeks

Arms, Groups and Cohorts

  • Experimental: telbivudine

Clinical Trial Outcome Measures

Primary Measures

  • Serum HBV DNA
    • Time Frame: 48 weeks
    • serum HBV DNA negativity and decline from baseline at week 48

Secondary Measures

  • Serum HBeAg
    • Time Frame: 48 weeks
    • rate of HBeAg seroconversion and HBeAg loss
  • Child-pugh score
    • Time Frame: 48 weeks
    • the average decline of Child-pugh score at week 48 from baseline

Participating in This Clinical Trial

Inclusion Criteria

  • liver cirrhosis with CHB – without history of antiviral therapy or discontinued antiviral therapy for more than 6 months – for patients with compensated liver cirrhosis: HBV DNA≥4log copies/ml if HBeAg positive,HBV DNA≥3log copies/ml if HBeAg negative – for patients with uncompensated liver cirrhosis:HBV DNA positive Exclusion Criteria:

  • coinfection with HCV,HDV and HIV – AFP≥100mg/L or HCC diagnosed by iconography – with severe cardiovascular, respiratory and endocrinology diseases or autoimmune diseases

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • The Fifth People’s Hospital of Suzhou
  • Provider of Information About this Clinical Study
    • Chuanwu Zhu, the Fifth People’s Hospital of Suzhou
  • Overall Official(s)
    • Chuanwu Zhu, Doctor, Principal Investigator, The Fifth People’s Hospital of Suzhou

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