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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Ju Seung Kim, MD, Gachon University Gil Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01776814
First Posted: January 28, 2013
Last Update Posted: January 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ju Seung Kim, MD, Gachon University Gil Medical Center
  Purpose
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.

Condition
Chronic Hepatitis B

Study Type: Observational
Study Design: Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Ju Seung Kim, MD, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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


Estimated Enrollment: 100
Study Start Date: February 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
treatment of nucleos(t)ide-naive patients who were diagnosed with chronic hepatitis B in Korea
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01776814


Contacts
Contact: Ju Seung Kim, Fellow +80+32 460 2792 joojoomj@gilhospital.com

Locations
Korea, Republic of
Gachon University Gil Medical Center, Department of Gastroenterology Not yet recruiting
Incheon, Korea, Republic of, 405-760
Contact: Ju Seung Kim, Fellow    +82 +32 460 2792    joojoomj@gilhospital.com   
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Responsible Party: Ju Seung Kim, MD, principle investigator, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01776814     History of Changes
Other Study ID Numbers: GAIRB2963-2012
First Submitted: January 18, 2013
First Posted: January 28, 2013
Last Update Posted: January 28, 2013
Last Verified: January 2013

Keywords provided by Ju Seung Kim, MD, Gachon University Gil Medical Center:
Entecair
Tenofovir

Additional relevant MeSH terms:
Hepatitis
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Tenofovir
Antiviral Agents
Anti-Infective Agents
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Anti-HIV Agents