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

NCT ID: NCT01776814

Last Updated: 2013-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gachon University Gil Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Ju Seung Kim, MD

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gachon University Gil Medical Center, Department of Gastroenterology

Incheon, , South Korea

Site Status

Countries

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South Korea

Central Contacts

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Ju Seung Kim, Fellow

Role: CONTACT

+80+32 460 2792

Facility Contacts

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Ju Seung Kim, Fellow

Role: primary

+82 +32 460 2792

Other Identifiers

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GAIRB2963-2012

Identifier Type: -

Identifier Source: org_study_id

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