Clinical trial NCT01720238: Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
Official title: Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Cirrhosis
Hepatitis B
Keywords: Compensated Liver Cirrhosis
Early Antiviral Therapy
Cost Effectiveness
Lead sponsor: Beijing Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Peking University First Hospital
name: Peking University People's Hospital
name: Beijing YouAn Hospital
name: Beijing Tiantan Hospital
name: Beijing Ditan Hospital
name: Peking Union Medical College Hospital
name: Beijing 302 Hospital
First posted: 2012-11-02
Enrollment: 621
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: compensated HBV Related liver cirrhosis

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.


Eligibility criteria: 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

Primary outcomes:
measure: Decompensation rate of liver cirrhosis
timeFrame: 3 years
Secondary outcomes:
measure: child-pugh score
timeFrame: 1,2 and 3 years
measure: HBVDNA undetected
timeFrame: 1,2 and 3 years
measure: liver elasticity
timeFrame: 1, 2, and 3 years
measure: life quality score
timeFrame: 1, 2 and 3 years
measure: cost-effectiveness
timeFrame: 1, 2 and 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friendship Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing 302 Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Ditan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing YouAn Hospital
state: Beijing
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
city: Beijing
country: China
facility: PeKing University People's Hopital
state: Beijing
city: Beijing
country: China
facility: The First Hospital of Peking University
state: Beijing
Study officials:
affiliation: Beijing Friendship Hospital
name: Dong Ji Jia, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wu X, Zhou J, Sun Y, Ding H, Chen G, Xie W, Piao H, Xu X, Jiang W, Ma H, Ma A, Chen Y, Xu M, Cheng J, Xu Y, Meng T, Wang B, Chen S, Shi Y, Kong Y, Ou X, You H, Jia J. Prediction of liver-related events in patients with compensated HBV-induced cirrhosis receiving antiviral therapy. Hepatol Int. 2021 Feb;15(1):82-92. doi: 10.1007/s12072-020-10114-1. Epub 2021 Jan 18.