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Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:
NCT00663182
First received: April 21, 2008
Last updated: April 22, 2008
Last verified: April 2008

April 21, 2008
April 22, 2008
January 2008
December 2010   (final data collection date for primary outcome measure)
  • liver function [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • HBV-DNA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
liver function and HBV-DNA [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00663182 on ClinicalTrials.gov Archive Site
  • disease progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • hepatocellular carcinoma [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • Child-Pugh score [ Time Frame: 2 year ] [ Designated as safety issue: No ]
  • motality [ Time Frame: 2 year ] [ Designated as safety issue: No ]
disease progression,hepatocellular carcinoma,Child-Pugh score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis
Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial

The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.

Chronic hepatitis B is one of the most widespread viral infections worldwide, potentially leading to liver cirrhosis and hepatocellular carcinoma. Previous studies demonstrated that patients with active viral replication, defined as the presence of detectable serum HBV-DNA or HBeAg, were at increased risk of developing progressive liver disease or death.The prognosis of decompensated cirrhosis resulting from chronic hepatitis B virus infection is poor. Anti-viral therapy in decompensated HBV-related cirrhosis has been recommended by the American Association for the Study of Liver Diseases. However, no high quality research on the effectiveness of anti-viral therapy in decompensated cirrhosis has been performed.

Entecavir is a new nucleotide analogue, which has been proved effective in suppressing viral replication and decreasing the necroinflammatory response, was recommended as a first-line medication in AASLD guideline. Our purpose was to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis. The main outcomes were liver function, HBV-DNA, disease progression, hepatocellular carcinoma, Child-Pugh score and the survival.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatitis B Virus
  • Decompensated Cirrhosis
Drug: Entecavir
Entecavir 0.5 mg/d
Other Name: Baraclude
  • Experimental: A
    Patients with decompensated HBV-related cirrhosis
    Intervention: Drug: Entecavir
  • No Intervention: B
    Untreated

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
200
December 2012
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. over 16 years of age;
  2. evidence of active viral replication was documented by a positive test for HBV-DNA in serum;
  3. Liver cirrhosis was proven by ultrasound or CT;
  4. Decompensated cirrhosis was evidenced by a Child-Pugh score ≥ 7;
  5. patients had decompensation signs such as jaundice, ascites, variceal bleeding, hepatic encephalopathy

Exclusion Criteria:

  1. evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein)
  2. a serum alanine aminotransferase level more than 10 times the upper limit of normal
  3. coinfection with hepatitis C or D virus or human immunodeficiency virus
  4. other types of cirrhosis
  5. a history of anti-viral therapy
  6. a total bilirubin level higher than 170 mmol/L
  7. a history of malignant tumors
Both
16 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00663182
Entecavir-01
Yes
Jian Shi, Shanghai Changzheng Hospital
Shanghai Changzheng Hospital
Not Provided
Principal Investigator: Jian Shi, MD Shanghai Changzheng Hospital
Shanghai Changzheng Hospital
April 2008

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