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Status unknownNCT01720238Updated Jul 28, 2015

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

An observational study in Liver Cirrhosis and Hepatitis B, sponsored by Beijing Friendship Hospital. Status unknown at 8 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-07-28.

Sponsored by Beijing Friendship Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2015), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
621
Ages
18 Years to 70 Years
Sex
All
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Study 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.

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Conditions studied

  • Liver Cirrhosis
  • Hepatitis B

Keywords

  • Compensated Liver Cirrhosis
  • Early Antiviral Therapy
  • Cost Effectiveness
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In context

Hepatitis B

1,656 studies on the registry are indexed under Hepatitis B; 196 are open to participants now.

This study's enrollment of 621 is above the median of 390 across 407 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Beijing Friendship Hospital is the lead sponsor of 216 studies on the registry; 95 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

compensated HBV Related liver cirrhosis

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
621 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • Group 1

    Entecavir Therapy

    Drug: Entecavir

  • Group 2

    Lamivudine plus Adefovir Dipivoxil Therapy

    Drug: Lamivudine plus Adefovir Dipivoxil

Interventions

  • DrugEntecavir

    0.5mg qd

    Also known as: Baraclude, other manufacturers

  • DrugLamivudine plus Adefovir Dipivoxil

    Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd

    Also known as: Heptodin, other manufactures

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What researchers measure

Primary outcomes

  1. Decompensation rate of liver cirrhosis

    presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC

    Time frame: 3 years

Secondary outcomes

  1. child-pugh score

    Time frame: 1,2 and 3 years

  2. HBVDNA undetected

    Time frame: 1,2 and 3 years

  3. liver elasticity

    Time frame: 1, 2, and 3 years

  4. life quality score

    Time frame: 1, 2 and 3 years

  5. cost-effectiveness

    Time frame: 1, 2 and 3 years

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Study locations

8 sites
  • Beijing Friendship Hospital
    Beijing, Beijing 100050, China
  • Beijing 302 Hospital
    Beijing, Beijing, China
  • Beijing Ditan Hospital
    Beijing, Beijing, China
  • Beijing Tiantan Hospital
    Beijing, Beijing, China
  • Beijing YouAn Hospital
    Beijing, Beijing, China
  • Peking Union Medical College Hospital
    Beijing, Beijing, China
  • PeKing University People's Hopital
    Beijing, Beijing, China
  • The First Hospital of Peking University
    Beijing, Beijing, China
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References and documents

Publications

  • 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. PubMed 33460002 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01720238
Lead sponsor
Beijing Friendship Hospital
Collaborators
Peking University First Hospital, Peking University People's Hospital, Beijing YouAn Hospital, Beijing Tiantan Hospital, Beijing Ditan Hospital, Peking Union Medical College Hospital, Beijing 302 Hospital
Responsible party
Jia Ji-Dong (Director of Liver Research Center, Beijing Friendship Hospital) — Principal investigator
First posted
Nov 2, 2012
Start date
Mar 2012
Primary completion
Dec 2015 (estimated)
Completion
Dec 2018 (estimated)
Last update
Jul 28, 2015

Study contacts

Dong Ji Jia, Doctor
principal investigator · Beijing Friendship Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.

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