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A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection

NCT ID: NCT00393484

Last Updated: 2014-11-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2013-09-30

Brief Summary

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Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, \<300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable (noninferior) and potentially superior to lamivudine, 100 mg once daily, in adults with hepatitis B e antigen-negative chronic hepatitis B virus infection.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Arm A

Entecavir + Lamivudine placebo (0-96 weeks)

Entecavir (96-240 weeks)

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)

Lamivudine Placebo

Intervention Type DRUG

Capsules, Oral, 0 mg, once daily (0-96 weeks)

Arm B

Lamivudine + Entecavir placebo (0-96 weeks)

Lamivudine (96-240 weeks)

Group Type ACTIVE_COMPARATOR

Lamivudine

Intervention Type DRUG

Capsules, Oral, 100 mg, once daily (0-96 weeks)

Tablets, Oral, 100 mg, once daily (96-240 weeks)

Entecavir Placebo

Intervention Type DRUG

Tablets, Oral, 0 mg, once daily (0-96 weeks)

Interventions

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Entecavir

Tablets, Oral, 0.5 mg, once daily (0-96 weeks) and (96-240 weeks)

Intervention Type DRUG

Lamivudine Placebo

Capsules, Oral, 0 mg, once daily (0-96 weeks)

Intervention Type DRUG

Lamivudine

Capsules, Oral, 100 mg, once daily (0-96 weeks)

Tablets, Oral, 100 mg, once daily (96-240 weeks)

Intervention Type DRUG

Entecavir Placebo

Tablets, Oral, 0 mg, once daily (0-96 weeks)

Intervention Type DRUG

Other Intervention Names

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Baraclude BMS-200475

Eligibility Criteria

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Inclusion Criteria

* Nucleoside and nucleotide-naive subjects with chronic HBV infection
* Hepatitis B Surface antigen(HBsAg)-positive ≥6 months
* Detectable HBsAg
* HBV DNA ≥ 105 copies/mL by PCR
* ALT 1.3 to 10 x the ULN
* HBeAg negative, anti-hepatitis B Virus E antigen antibody (anti-HBeAb) positive status
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

Bucheon-si, , South Korea

Site Status

Local Institution

Busan, , South Korea

Site Status

Local Institution

Chuncheon, , South Korea

Site Status

Local Institution

Daegu, , South Korea

Site Status

Local Institution

Daegu, , South Korea

Site Status

Local Institution

Daejeon, , South Korea

Site Status

Local Institution

Guri-si, , South Korea

Site Status

Local Institution

Jeonju, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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AI463-105

Identifier Type: -

Identifier Source: org_study_id