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

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ClinicalTrials.gov Identifier: NCT01720238
Recruitment Status : Active, not recruiting
First Posted : November 2, 2012
Last Update Posted : July 28, 2015
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Liver Cirrhosis Hepatitis B Drug: Entecavir Drug: Lamivudine plus Adefovir Dipivoxil

Study Design

Study Type : Observational
Actual Enrollment : 621 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
Study Start Date : March 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cirrhosis
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Group 1
Entecavir Therapy
Drug: Entecavir
0.5mg qd
Other Names:
  • Baraclude
  • other manufacturers
Group 2
Lamivudine plus Adefovir Dipivoxil Therapy
Drug: Lamivudine plus Adefovir Dipivoxil
Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd
Other Names:
  • Heptodin
  • other manufactures

Outcome Measures

Primary Outcome Measures :
  1. Decompensation rate of liver cirrhosis [ Time Frame: 3 years ]
    presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
serum,plasma and DNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01720238

China, Beijing
Beijing Friendship Hospital
Beijing, Beijing, China, 100050
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
Sponsors and Collaborators
Beijing Friendship Hospital
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
Principal Investigator: Dong Ji Jia, Doctor Beijing Friendship Hospital
More Information

Responsible Party: Jia Ji-Dong, Director of Liver Research Center, Beijing Friendship Hospital
ClinicalTrials.gov Identifier: NCT01720238     History of Changes
Other Study ID Numbers: D1211000039120003
First Posted: November 2, 2012    Key Record Dates
Last Update Posted: July 28, 2015
Last Verified: July 2015

Keywords provided by Jia Ji-Dong, Beijing Friendship Hospital:
Compensated Liver Cirrhosis
Early Antiviral Therapy
Cost Effectiveness

Additional relevant MeSH terms:
Hepatitis B
Liver Cirrhosis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Pathologic Processes
Adefovir dipivoxil
Antiviral Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-Infective Agents
Anti-HIV Agents