Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

621

participants targeted

Target at P75+ for all trials

Timeline

Completed

Started Mar 2012

Longer than P75 for all trials

Geographic Reach

1 country

8 active sites

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

6.8 years study duration

Study Start

First participant enrolled

March 1, 2012

Completed

8 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2012

Completed

2 days until next milestone

First Posted

Study publicly available on registry

November 2, 2012

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed

3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed

Last Updated

July 28, 2015

Status Verified

July 1, 2015

Enrollment Period

3.8 years

First QC Date

October 31, 2012

Last Update Submit

July 27, 2015

Conditions

Liver Cirrhosis Hepatitis B

Keywords

Compensated Liver CirrhosisEarly Antiviral TherapyCost Effectiveness

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (5)

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

Study Arms (2)

Group 1

Entecavir Therapy

Drug: Entecavir

Group 2

Lamivudine plus Adefovir Dipivoxil Therapy

Drug: Lamivudine plus Adefovir Dipivoxil

Interventions

EntecavirDRUG

0.5mg qd

Also known as: Baraclude, other manufacturers

Group 1

Lamivudine plus Adefovir DipivoxilDRUG

Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd

Also known as: Heptodin, other manufactures

Group 2

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

compensated HBV Related liver cirrhosis

You may qualify if:

written informed consent
aged 18-70 years
clinical diagnosis of compensated liver cirrhosis
liver biopsy showing cirrhosis
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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Study Sites (8)

Beijing Friendship Hospital

Beijing, Beijing Municipality, 100050, China

Location

Beijing 302 Hospital