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A Phase IIIb Study to Compare Entecavir Plus Tenofovir vs. Adefovir Added to Continuing Lamivudine Therapy in Adult Patients With Lamivudine-Resistant Hepatitis B Infection

NCT ID: NCT00605384

Last Updated: 2010-11-23

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this clinical research study is to find out whether a combination of entecavir (ETV) plus tenofovir (TNF) works better against Hepatitis B virus than adefovir (ADV) added to continuing lamivudine (LVD) therapy in patients whose Hepatitis B virus (HBV) is resistant against lamivudine. The safety of this treatment will also be studied.

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

NONE

Study Groups

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1

Group Type EXPERIMENTAL

Entecavir + Tenofovir

Intervention Type DRUG

Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks

2

Group Type EXPERIMENTAL

Adefovir + continuing Lamivudine

Intervention Type DRUG

Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks

Interventions

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Entecavir + Tenofovir

Tablets, Oral Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks

Intervention Type DRUG

Adefovir + continuing Lamivudine

Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks

Intervention Type DRUG

Other Intervention Names

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Baraclude

Eligibility Criteria

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Inclusion Criteria

* Chronic HBV infection
* History of lamivudine (LVD) treatment, and lamivudine resistance (LVDr), receiving LVD at screening visit
* Compensated liver function
* HBV DNA ≥ 172,000 IU/mL
* Hepatitis B e-antigen (HBeAg)-positive or HBeAg-negative

Exclusion Criteria

* Evidence of decompensated cirrhosis
* Coinfection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis D virus (HDV)
* Recent history of pancreatitis
* Serum alpha fetoprotein \> 100 ng/mL
* Except lamivudine, any prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B
Minimum Eligible Age

18 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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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status

Kaiser Permanente Medical Center

San Francisco, California, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Local Institution

New York, New York, United States

Site Status

Local Institution

Brussels, , Belgium

Site Status

Local Institution

Leuven, , Belgium

Site Status

Local Institution

Berlin, , Germany

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Local Institution

Bonn, , Germany

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Local Institution

Düsseldorf, , Germany

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Local Institution

Mainz, , Germany

Site Status

Local Institution

Messina, , Italy

Site Status

Local Institution

Modena, , Italy

Site Status

Local Institution

Naples, , Italy

Site Status

Local Institution

Padua, , Italy

Site Status

Local Institution

San Giovanni Rotondo, , Italy

Site Status

Local Institution

Chorzów, , Poland

Site Status

Local Institution

Krakow, , Poland

Site Status

Local Institution

Lublin, , Poland

Site Status

Local Institution

Ankara, , Turkey (Türkiye)

Site Status

Local Institution

Ankara, , Turkey (Türkiye)

Site Status

Local Institution

Istanbul, , Turkey (Türkiye)

Site Status

Local Institution

Istanbul, , Turkey (Türkiye)

Site Status

Local Institution

Istanbul, , Turkey (Türkiye)

Site Status

Local Institution

Istanbul, , Turkey (Türkiye)

Site Status

Local Institution

Istanbul, , Turkey (Türkiye)

Site Status

Local Institution

Izmir, , Turkey (Türkiye)

Site Status

Local Institution

Kocaeli, , Turkey (Türkiye)

Site Status

Local Institution

Sihhiye Ankara, , Turkey (Türkiye)

Site Status

Local Institution

Trabzon, , Turkey (Türkiye)

Site Status

Countries

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United States Belgium Germany Italy Poland Turkey (Türkiye)

Other Identifiers

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AI463-137

Identifier Type: -

Identifier Source: org_study_id