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

January 25, 2013 updated by: Ju Seung Kim, MD, Gachon University Gil Medical Center
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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Incheon, Korea, Republic of, 405-760
        • Gachon University Gil Medical Center, Department of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

treatment of nucleos(t)ide-naive patients who were diagnosed with chronic hepatitis B in Korea

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
changes from baseline HBV DNA level at 3, 6, 9, 12 months after taking entecavir or tenofovir

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
reduction of alanine transaminase
Time Frame: changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir
Patients will check the level of alanine transaminasel at 3, 6, 9, 12 months after taking entecavir and tenofovir
changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gachon University Gil Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Anticipated)

February 1, 2013

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 25, 2013

First Posted (Estimate)

January 28, 2013

Study Record Updates

Last Update Posted (Estimate)

January 28, 2013

Last Update Submitted That Met QC Criteria

January 25, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GAIRB2963-2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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