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

This study is currently recruiting participants. (see Contacts and Locations)
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

October 31, 2012
November 1, 2012
March 2012
December 2014   (final data collection date for primary outcome measure)
Decompensation rate of liver cirrhosis [ Time Frame: 3 years ] [ Designated as safety issue: No ]
presence of ascites, variceal hemorrhage, hepatic encephalopathy and HCC
Same as current
Complete list of historical versions of study NCT01720238 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis
Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

serum,plasma and DNA

Non-Probability Sample

compensated HBV Related liver cirrhosis

  • Liver Cirrhosis
  • Hepatitis B
  • Drug: Entecavir
    0.5mg qd
    Other Names:
    • Baraclude
    • other manufacturers
  • Drug: Lamivudine plus Adefovir Dipivoxil
    Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd
    Other Names:
    • Heptodin
    • other manufactures
  • Group 1
    Entecavir Therapy
    Intervention: Drug: Entecavir
  • Group 2
    Lamivudine plus Adefovir Dipivoxil Therapy
    Intervention: Drug: Lamivudine plus Adefovir Dipivoxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
800
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Dong ji Jia, Doctor 8610-63139816 jiamd@263.net
Contact: Hong You, Doctor 8610-63139019 youhong30@sina.com
China
 
NCT01720238
D1211000039120003
Yes
Jia Ji-Dong, Beijing Friendship Hospital
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
Beijing Friendship Hospital
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP