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

• Conditions: Liver Cirrhosis; Hepatitis B
• Interventions: Drug: Lamivudine plus Adefovir Dipivoxil; Drug: Entecavir

• Registration Number: NCT01720238
• Lead Sponsor: Beijing Friendship Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03
• Study First Submitted: 2012-10-31
• Study First Submitted QC: 2012-11-01
• Study First Posted: 2012-11-02
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-27
• Last Update Posted: 2015-07-28
• Primary Completion: 2015-12
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 621

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group 2	Lamivudine plus Adefovir Dipivoxil	Lamivudine plus Adefovir Dipivoxil Therapy
Group 1	Entecavir	Entecavir Therapy

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (8)

Beijing 302 Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Ditan Hospital; 🇨🇳 Beijing, Beijing, China

PeKing University People's Hopital; 🇨🇳 Beijing, Beijing, China

Beijing Tiantan Hospital; 🇨🇳 Beijing, Beijing, China

Beijing Friendship Hospital; 🇨🇳 Beijing, Beijing, China

Beijing YouAn Hospital; 🇨🇳 Beijing, Beijing, China

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China

The First Hospital of Peking University; 🇨🇳 Beijing, Beijing, China