NCT01776814

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2013

Completed
10 days until next milestone

First Posted

Study publicly available on registry

January 28, 2013

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

January 28, 2013

Status Verified

January 1, 2013

Enrollment Period

Same day

First QC Date

January 18, 2013

Last Update Submit

January 25, 2013

Conditions

Chronic Hepatitis B

Keywords

EntecairTenofovir

Outcome Measures

Primary Outcomes (1)

  • virologic response

    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 Outcomes (1)

  • reduction of alanine transaminase

    changes from baseline ALT level at 3,6,9,12 months after taking entecavir or tenofovir

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • \< 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 (-)

You may not qualify if:

  • With HCV or other liver disease
  • With kidney disease
  • decompensated liver cirrhosis
  • with hepatocellular carcinoma
  • refuse this clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gachon University Gil Medical Center, Department of Gastroenterology

Incheon, 405-760, South Korea

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Ju Seung Kim, Fellow

CONTACT

+80+32 460 2792joojoomj@gilhospital.com

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

January 18, 2013

First Posted

January 28, 2013

Study Start

February 1, 2013

Primary Completion

February 1, 2013

Last Updated

January 28, 2013

Record last verified: 2013-01

Locations

KR(1)