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

This study is currently recruiting participants.
Verified October 2012 by Beijing Friendship Hospital
Sponsor:
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
Information provided by (Responsible Party):
Jia Ji-Dong, Beijing Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01720238
First received: October 31, 2012
Last updated: November 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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 Intervention
Liver Cirrhosis
Hepatitis B
 Drug: Entecavir
Drug: Lamivudine plus Adefovir Dipivoxil

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Beijing Friendship Hospital:

Primary Outcome Measures:
  • Decompensation rate of liver cirrhosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC


Secondary Outcome Measures:
  • child-pugh score [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]
  • HBVDNA undetected [ Time Frame: 1,2 and 3 years ] [ Designated as safety issue: No ]
  • liver elasticity [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • life quality score [ Time Frame: 1, 2 and 3 years ] [ Designated as safety issue: No ]
  • cost-effectiveness [ Time Frame: 1, 2 and 3 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum,plasma and DNA


Estimated Enrollment: 800
Study Start Date: March 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

compensated HBV Related liver cirrhosis

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720238

Contacts
Contact: Dong ji Jia, Doctor 8610-63139816 jiamd@263.net
Contact: Hong You, Doctor 8610-63139019 youhong30@sina.com

Locations
China, Beijing
Beijing Friendship Hospital Recruiting
Beijing, Beijing, China, 100050
Contact: Ning X Wu, Doctor     8610-63138665     wuxiaoningbs@yahoo.com.cn    
The First Hospital of Peking University Recruiting
Beijing, Beijing, China
Contact: Yuan X Xu, Doctor     8613001185762     yangpin@public.bta.net.cn    
PeKing University People's Hopital Recruiting
Beijing, Beijing, China
Contact: Hui Ma, Doctor     8613671090481     mahui_wj@163.com    
Beijing YouAn Hospital Recruiting
Beijing, Beijing, China
Contact: Guo H Ding, Doctor     8613699119545     Lilei_1978@yahoo.com.cn    
Beijing Tiantan Hospital Recruiting
Beijing, Beijing, China
Contact: Qing Y Xu            
Beijing Ditan Hospital Recruiting
Beijing, Beijing, China
Contact: Wen Xie            
Beijing 302 Hospital Recruiting
Beijing, Beijing, China
Contact: Feng G Chen            
Peking Union Medical College Hospital Recruiting
Beijing, Beijing, China
Contact: Qing X Liu            
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
Investigators
Principal Investigator: Dong Ji Jia, Doctor Beijing Friendship Hospital
  More Information

No publications provided

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
Study First Received: October 31, 2012
Last Updated: November 1, 2012
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Beijing Friendship Hospital:
Compensated Liver Cirrhosis
Early Antiviral Therapy
Cost Effectiveness

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes
 Adefovir
Adefovir dipivoxil
Lamivudine
Entecavir
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents

ClinicalTrials.gov processed this record on May 22, 2013