Trials / Unknown
UnknownNCT00663182
Entecavir for Patients With Decompensated Hepatitis B Virus (HBV)-Related Cirrhosis
Entecavir for Patients With Decompensated HBV-Related Cirrhosis:a Prospective Randomized Controlled Trial
- Status
- Unknown
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- Sponsor
- Shanghai Changzheng Hospital · Academic / Other
- Sex
- All
- Age
- 16 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Entecavir | Entecavir 0.5 mg/d |
Timeline
- Start date
- 2008-01-01
- Primary completion
- 2010-12-01
- Completion
- 2012-12-01
- First posted
- 2008-04-22
- Last updated
- 2008-04-23
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT00663182. Inclusion in this directory is not an endorsement.