Clinical trial NCT00663182: Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis
Official title: Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hepatitis B Virus
Decompensated Cirrhosis
Keywords: Entecavir
cirrhosis
anti-viral
therapy
Lead sponsor: Shanghai Changzheng Hospital
Sponsor class: OTHER
First posted: 2008-04-22
Enrollment: 200
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: liver function
timeFrame: 1 year
measure: HBV-DNA
timeFrame: 1 year
Secondary outcomes:
measure: disease progression
timeFrame: 2 years
measure: hepatocellular carcinoma
timeFrame: 2 year
measure: Child-Pugh score
timeFrame: 2 year
measure: motality
timeFrame: 2 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai changzheng Hospital
state: Shanghai
Study officials:
affiliation: Shanghai Changzheng Hospital
name: Jian Shi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJMoa033364.
citation: 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. doi: 10.1111/j.1365-2893.2005.00608.x.
citation: 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. doi: 10.1002/hep.510310130.