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

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