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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

This study is not yet open for participant recruitment.
Verified January 2013 by Gachon University Gil Medical Center
Sponsor:
Information provided by (Responsible Party):
Ju Seung Kim, MD, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01776814
First received: January 18, 2013
Last updated: January 25, 2013
Last verified: January 2013
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 18, 2013
Last Updated: January 25, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
Entecair
Tenofovir

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

ClinicalTrials.gov processed this record on May 19, 2013