NCT01776814UnknownNot Applicable
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 Center1 site in 1 country100 target enrollmentStarted: February 2013Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- virologic response
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
virologic response
Time Frame: changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir
Patients will check the HBV DNA level at 3, 6, 9, 12 months after taking entecavir and tenofovir
Secondary Outcomes
- reduction of alanine transaminase(changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir)
Investigators
Ju Seung Kim, MD
principle investigator
Gachon University Gil Medical Center
Study Sites (1)
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