Overview

This trial is active, not recruiting.

Conditions liver cirrhosis, hepatitis b
Treatments entecavir, lamivudine plus adefovir dipivoxil
Sponsor Beijing Friendship Hospital
Collaborator Peking University First Hospital
Start date March 2012
End date December 2015
Trial size 621 participants
Trial identifier NCT01720238, D1211000039120003

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Entecavir Therapy
entecavir Baraclude
0.5mg qd
Lamivudine plus Adefovir Dipivoxil Therapy
lamivudine plus adefovir dipivoxil Heptodin
Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd

Primary Outcomes

Measure
Decompensation rate of liver cirrhosis
time frame: 3 years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
Principal investigator Dong Ji Jia, Doctor
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Beijing Friendship Hospital.