Comparative Trial of Entecavir Versus Adefovir in the Treatment of Chronic Hepatitis B Infection

NCT ID: NCT00096785

Last Updated: 2010-08-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study is to evaluate antiviral activity and efficacy of entecavir (ETV) compared to adefovir in adults with chronic hepatitis B who have not been treated yet with an antiviral medicine.

Detailed Description

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Conditions

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Hepatitis B Chronic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A1

Group Type ACTIVE_COMPARATOR

entecavir

Intervention Type DRUG

Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks

A2

Group Type ACTIVE_COMPARATOR

adefovir

Intervention Type DRUG

Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks

Interventions

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entecavir

Tablets, Oral, ETV 0.5 mg, once daily, up to 96 weeks

Intervention Type DRUG

adefovir

Tablets, Oral, ADV 10 mg, once daily, up to 96 weeks

Intervention Type DRUG

Other Intervention Names

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Baraclude

Eligibility Criteria

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Inclusion Criteria

* Chronic hepatitis B treatment naive
* Compensated liver disease
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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Bristol-Myers Squibb

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Local Institution

San Diego, California, United States

Site Status

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San Francisco, California, United States

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Torrance, California, United States

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Miami, Florida, United States

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North Miami Beach, Florida, United States

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Baltimore, Maryland, United States

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New York, New York, United States

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New York, New York, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Edmonton, Alberta, Canada

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Vancouver, British Columbia, Canada

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Toronto, Ontario, Canada

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Chai Wan, , Hong Kong

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Pokfulham, , Hong Kong

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Tai Po, , Hong Kong

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Jakarta, , Indonesia

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Cebu, , Philippines

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Manila, , Philippines

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Singapore, , Singapore

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Taichung, , Taiwan

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Taoyan, , Taiwan

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Bangkok, , Thailand

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Countries

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United States Canada Hong Kong Indonesia Philippines Singapore Taiwan Thailand

References

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Leung N, Peng CY, Hann HW, Sollano J, Lao-Tan J, Hsu CW, Lesmana L, Yuen MF, Jeffers L, Sherman M, Min A, Mencarini K, Diva U, Cross A, Wilber R, Lopez-Talavera J. Early hepatitis B virus DNA reduction in hepatitis B e antigen-positive patients with chronic hepatitis B: A randomized international study of entecavir versus adefovir. Hepatology. 2009 Jan;49(1):72-9. doi: 10.1002/hep.22658.

Reference Type BACKGROUND
PMID: 19065670 (View on PubMed)

Other Identifiers

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AI463-079

Identifier Type: -

Identifier Source: org_study_id

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