UnknownPhase 4

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

China200 participantsStarted 2008-01

Plain-language summary

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

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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

✕. 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

liver function

Timeframe: 1 year

HBV-DNA

Timeframe: 1 year

NCT IDNCT00663182

SponsorShanghai Changzheng Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-12