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

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. Identifier: NCT00663182
Recruitment Status : Unknown
Verified April 2008 by Shanghai Changzheng Hospital.
Recruitment status was:  Enrolling by invitation
First Posted : April 22, 2008
Last Update Posted : April 23, 2008
Information provided by:
Shanghai Changzheng Hospital

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

Condition or disease Intervention/treatment Phase
Hepatitis B Virus Decompensated Cirrhosis Drug: Entecavir Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Study Start Date : January 2008
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: A
Patients with decompensated HBV-related cirrhosis
Drug: Entecavir
Entecavir 0.5 mg/d
Other Name: Baraclude

No Intervention: B

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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

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 identifier (NCT number): NCT00663182

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China, Shanghai
Shanghai changzheng Hospital
Shanghai, Shanghai, China, 200003
Sponsors and Collaborators
Shanghai Changzheng Hospital
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Principal Investigator: Jian Shi, MD Shanghai Changzheng Hospital
Publications of Results:
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Responsible Party: Jian Shi, Shanghai Changzheng Hospital Identifier: NCT00663182    
Other Study ID Numbers: Entecavir-01
First Posted: April 22, 2008    Key Record Dates
Last Update Posted: April 23, 2008
Last Verified: April 2008
Keywords provided by Shanghai Changzheng Hospital:
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Liver Cirrhosis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Pathologic Processes
Antiviral Agents
Anti-Infective Agents