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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

621 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2018-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Cirrhosis Hepatitis B

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Entecavir Therapy

Entecavir

Intervention Type DRUG

0.5mg qd

Group 2

Lamivudine plus Adefovir Dipivoxil Therapy

Lamivudine plus Adefovir Dipivoxil

Intervention Type DRUG

Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd

Interventions

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Entecavir

0.5mg qd

Intervention Type DRUG

Lamivudine plus Adefovir Dipivoxil

Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd

Intervention Type DRUG

Other Intervention Names

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Baraclude other manufacturers Heptodin other manufactures

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No