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
  Purpose

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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
  • HBV-DNA [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
Untreated

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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00663182

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

Publications:
Responsible Party: Jian Shi, Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier: NCT00663182     History of Changes
Other Study ID Numbers: Entecavir-01
Study First Received: April 21, 2008
Last Updated: April 22, 2008
Health Authority: China: Ministry of Health

Keywords provided by Shanghai Changzheng Hospital:
Entecavir
cirrhosis
anti-viral
therapy

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Liver Cirrhosis
Digestive System Diseases
DNA Virus Infections
Enterovirus Infections
Hepadnaviridae Infections
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Entecavir
Anti-Infective Agents
Antiviral Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014