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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Shanghai Changzheng Hospital.
Recruitment status was:  Enrolling by invitation
ClinicalTrials.gov Identifier:
First Posted: April 22, 2008
Last Update Posted: April 23, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shanghai Changzheng Hospital
The aim of this study is to evaluate the effect of Entecavir for patients With decompensated HBV-Related cirrhosis.

Condition Intervention Phase
Hepatitis B Virus Decompensated Cirrhosis Drug: Entecavir Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial

Resource links provided by NLM:

Further study details as provided by Shanghai Changzheng Hospital:

Primary Outcome Measures:
  • liver function [ Time Frame: 1 year ]
  • HBV-DNA [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • disease progression [ Time Frame: 2 years ]
  • hepatocellular carcinoma [ Time Frame: 2 year ]
  • Child-Pugh score [ Time Frame: 2 year ]
  • motality [ Time Frame: 2 year ]

Estimated Enrollment: 200
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Patients with decompensated HBV-related cirrhosis
Drug: Entecavir
Entecavir 0.5 mg/d
Other Name: Baraclude
No Intervention: B

Detailed Description:

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.


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  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): NCT00663182

China, Shanghai
Shanghai changzheng Hospital
Shanghai, Shanghai, China, 200003
Sponsors and Collaborators
Shanghai Changzheng Hospital
Principal Investigator: Jian Shi, MD Shanghai Changzheng Hospital
  More Information

Responsible Party: Jian Shi, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT00663182     History of Changes
Other Study ID Numbers: Entecavir-01
First Submitted: April 21, 2008
First Posted: April 22, 2008
Last Update Posted: April 23, 2008
Last Verified: April 2008

Keywords provided by Shanghai Changzheng Hospital:

Additional relevant MeSH terms:
Hepatitis B
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Pathologic Processes
Antiviral Agents
Anti-Infective Agents