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

Sponsored by:	Shanghai Changzheng Hospital
Information provided by:	Shanghai Changzheng Hospital
ClinicalTrials.gov Identifier:	NCT00663182

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 IV

MedlinePlus related topics: Cirrhosis Hepatitis Hepatitis B

Drug Information available for: Entecavir

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Placebo Control, Single Group Assignment, Efficacy Study
Official Title:	Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial

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
A: Experimental Patients with decompensated HBV-related cirrhosis	Drug: Entecavir Entecavir 0.5 mg/d
B: No Intervention 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:

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

Exclusion Criteria:

evidence of hepatocellular carcinoma (suspicious foci on hepatic ultrasonography at screening or a rising serum level of alpha-fetoprotein)
a serum alanine aminotransferase level more than 10 times the upper limit of normal
coinfection with hepatitis C or D virus or human immunodeficiency virus
other types of cirrhosis
a history of anti-viral therapy
a total bilirubin level higher than 170 mmol/L
a history of malignant tumors

Contacts and Locations

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

Locations

China
Shanghai changzheng Hospital
Shanghai, China, 200003

Sponsors and Collaborators

Shanghai Changzheng Hospital

Investigators

Principal Investigator:

Jian Shi, MD

Shanghai Changzheng Hospital

More Information

Publications:

Liaw YF, Sung JJ, Chow WC, Farrell G, Lee CZ, Yuen H, Tanwandee T, Tao QM, Shue K, Keene ON, Dixon JS, Gray DF, Sabbat J; Cirrhosis Asian Lamivudine Multicentre Study Group. Lamivudine for patients with chronic hepatitis B and advanced liver disease. N Engl J Med. 2004 Oct 7;351(15):1521-31.

Tseng PL, Lu SN, Tung HD, Wang JH, Changchien CS, Lee CM. Determinants of early mortality and benefits of lamivudine therapy in patients with hepatitis B virus-related decompensated liver cirrhosis. J Viral Hepat. 2005 Jul;12(4):386-92.

Villeneuve JP, Condreay LD, Willems B, Pomier-Layrargues G, Fenyves D, Bilodeau M, Leduc R, Peltekian K, Wong F, Margulies M, Heathcote EJ. Lamivudine treatment for decompensated cirrhosis resulting from chronic hepatitis B. Hepatology. 2000 Jan;31(1):207-10.

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

Keywords provided by Shanghai Changzheng Hospital:

Entecavir
cirrhosis
anti-viral
therapy

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Liver Diseases
Entecavir
Digestive System Diseases
Fibrosis

Hepatitis B
Hepatitis, Viral, Human
DNA Virus Infections
Liver Cirrhosis
Antiviral Agents

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Fibrosis
Hepatitis, Viral, Human
Liver Cirrhosis
Hepadnaviridae Infections
Antiviral Agents
Pharmacologic Actions

Hepatitis
Virus Diseases
Digestive System Diseases
Pathologic Processes
Entecavir
Therapeutic Uses
Hepatitis B
DNA Virus Infections

ClinicalTrials.gov processed this record on May 07, 2009