Comparison of the Efficacy of Entecavir and Tenofovir Monotherapy for the Treatment of Nucleos(t)Ide-naïve Patients With Chronic Hepatitis B in Korea

G

Gachon University Gil Medical Center

Status

Unknown

Conditions

Chronic Hepatitis B

Study type

Observational

Funder types

Other

Identifiers

NCT01776814
GAIRB2963-2012

Details and patient eligibility

About

Chronic hepatitis B virus infection is an important cause of morbidity and mortality. Tenofovir disoproxil fumarate and entecavir were licensed for the treatment of hepatitis B virus infection. In this study, the investigators will try to make comparison between Entecavir and Tenofovir and investigate the efficacy.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 18 < Age < 70
  • HBV DNA > 100,000 copies/mL and increased ALT over 2 times compared with normal range if HBsAg (+), HBeAg (+)
  • HBV DNA > 10,000 copies/mL and increased ALT compared with normal range if HBsAg (+), HBeAg (-)

Exclusion criteria

  • With HCV or other liver disease
  • With kidney disease
  • decompensated liver cirrhosis
  • with hepatocellular carcinoma
  • refuse this clinical trials

Trial contacts and locations

1

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Central trial contact

Ju Seung Kim, Fellow

Data sourced from clinicaltrials.gov

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