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

Decompensated Cirrhosis Clinical Trial

Official title:

Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT00663182
• Other study ID #: Entecavir-01
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: April 21, 2008
• Last updated: April 22, 2008
• Start date: January 2008
• Est. completion date: December 2012

Study information

• Verified date: April 2008
• Source: Shanghai Changzheng Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 200
• Est. completion date: December 2012
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Decompensated Cirrhosis
• Hepatitis
• Hepatitis B
• Hepatitis B Virus
• Liver Cirrhosis

Intervention

Drug:
• Entecavir
Entecavir 0.5 mg/d

Locations

Country	Name	City	State
China	Shanghai changzheng Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Changzheng Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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 En — View 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. — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	liver function		1 year	No
Primary	HBV-DNA		1 year	No
Secondary	disease progression		2 years	No
Secondary	hepatocellular carcinoma		2 year	No
Secondary	Child-Pugh score		2 year	No
Secondary	motality		2 year	No