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Efficacy and Safety Study of Entecavir Plus Tenofovir in Patients With Chronic Hepatitis B Who Failed Previous Treatment

NCT ID: NCT01063036

Last Updated: 2014-12-15

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-02-28

Brief Summary

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The purpose of this study is to show that the combination of entecavir and tenofovir, is effective and well tolerated in chronic hepatitis B patients who have failed previous treatment.

Detailed Description

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Conditions

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Chronic Hepatitis B

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Entecavir + Tenofovir

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

Tablets, Oral, 1 mg, once daily, 96 weeks

Tenofovir

Intervention Type DRUG

Tablets, Oral, 300 mg, once daily, 96 weeks

Interventions

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Entecavir

Tablets, Oral, 1 mg, once daily, 96 weeks

Intervention Type DRUG

Tenofovir

Tablets, Oral, 300 mg, once daily, 96 weeks

Intervention Type DRUG

Other Intervention Names

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Baraclude® BMS-200475 Viread®

Eligibility Criteria

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Inclusion Criteria

* Subjects with chronic hepatitis B virus (HBV) infection; either hepatitis B-e antigen(HBeAg)-negative or HBeAg-positive
* Subjects must have a treatment failure to their current nucleoside/ nucleotide treatment regimen
* Prior entecavir and/or tenofovir monotherapy is allowed
* Subjects must have compensated liver function

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Evidence of decompensated cirrhosis
* Co-infection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)
* Moderate or severe renal impairment
* Recent history of pancreatitis
* Therapy with interferon, thymosin alpha or other immuno-stimulators within 24 weeks of being assigned to study drug into this study
* Prior entecavir/tenofovir combination therapy
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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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

Clichy, , France

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Lyon, , France

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Orléans, , France

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Strasbourg, , France

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Berlin, , Germany

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Berlin, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heindelberg, , Germany

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München, , Germany

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Tübingen, , Germany

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Bagno A Ripoli (Fi), , Italy

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Bari, , Italy

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Foggia, , Italy

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Milan, , Italy

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Amsterdam, , Netherlands

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Arnhem, , Netherlands

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Rotterdam, , Netherlands

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Kielce, , Poland

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Krakow, , Poland

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Lodz, , Poland

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Wroclaw, , Poland

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Bucharest, , Romania

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Burcuresti, , Romania

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Timișoara, , Romania

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Barcelona, , Spain

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Valencia, , Spain

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Countries

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Portugal France Germany Italy Netherlands Poland Romania Spain

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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2009-015705-40

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AI463-203

Identifier Type: -

Identifier Source: org_study_id