Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis
Information source: Shanghai Changzheng Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hepatitis B Virus; Decompensated Cirrhosis
Intervention: Entecavir (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Shanghai Changzheng Hospital Official(s) and/or principal investigator(s): Jian Shi, MD, Principal Investigator, Affiliation: Shanghai Changzheng Hospital
Summary
The aim of this study is to evaluate the effect of Entecavir for patients With decompensated
HBV-Related cirrhosis.
Clinical Details
Official title: Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: liver functionHBV-DNA
Secondary outcome: disease progressionhepatocellular carcinoma Child-Pugh score motality
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
Minimum age: 16 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Shanghai changzheng Hospital, Shanghai, Shanghai 200003, China
Additional Information
Starting date: January 2008
Last updated: April 22, 2008
|