Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis

Overview

Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. In view of economic development level, drug availability and lack of independent health economics evidence, the investigators are still unable to give specific guidelines for HBV related compensated liver cirrhosis in China. Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through this prospective, open-label, multicenter and nonrandomized study.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2015

Interventions

  • Drug: Entecavir
    • 0.5mg qd
  • Drug: Lamivudine plus Adefovir Dipivoxil
    • Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd

Arms, Groups and Cohorts

  • Group 1
    • Entecavir Therapy
  • Group 2
    • Lamivudine plus Adefovir Dipivoxil Therapy

Clinical Trial Outcome Measures

Primary Measures

  • Decompensation rate of liver cirrhosis
    • Time Frame: 3 years
    • presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC

Secondary Measures

  • child-pugh score
    • Time Frame: 1,2 and 3 years
  • HBVDNA undetected
    • Time Frame: 1,2 and 3 years
  • liver elasticity
    • Time Frame: 1, 2, and 3 years
  • life quality score
    • Time Frame: 1, 2 and 3 years
  • cost-effectiveness
    • Time Frame: 1, 2 and 3 years

Participating in This Clinical Trial

Inclusion Criteria

  • written informed consent – aged 18-70 years – clinical diagnosis of compensated liver cirrhosis 1. liver biopsy showing cirrhosis 2. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension 3. if no biopsy or endoscopy ,should meet two of the four: – Imaging(US, CT or MRI, et al) showing Surface nodularity: Echogenecity (spleen pachydiameter > 4.0cm or> 5 costal region) – PLT < 100×10 < 9 >/L,no other interpretation – ALB < 35.0 g/L, or INR > 1.3, or CHE < 5.0KU/L – Liver stiffness measurement value > 12.4 kpa – HBeAg(+)with HBVDNA > 10 < 3 > IU/mL or HBeAg(-) wtih HBVDNA > 102 IU/mL Exclusion Criteria:

  • patient with decompensated liver cirrhosis:presence of ascites, variceal hemorrhage,hepatic encephalopathy – allergic to any ingredients of the drugs – patient complicated with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease. – AFP > 100ng/ml or Cr > 1.5×ULN – pregnant woman – patient with severe disease or other organ failure – patient with any tumors – patient with sever mental disease. – patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beijing Friendship Hospital
  • Collaborator
    • Peking University First Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jia Ji-Dong, Director of Liver Research Center – Beijing Friendship Hospital
  • Overall Official(s)
    • Dong Ji Jia, Doctor, Principal Investigator, Beijing Friendship Hospital

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