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Safety and Antiviral Activity of Entecavir in Participants With Chronic Hepatitis B Following Monotherapy in Other Entecavir Trials

NCT ID: NCT01438424

Last Updated: 2012-08-23

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1053 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-01-31

Study Completion Date

2011-04-30

Brief Summary

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The purpose of this study is to provide entecavir to participants who have completed another entecavir trial without achieving virologic response or who relapsed during postdosing follow-up.

Detailed Description

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Conditions

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Hepatitis B Virus HBV

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, 1.0 mg, with or without lamivudine

Group Type EXPERIMENTAL

Entecavir

Intervention Type DRUG

Tablets, Oral, 1.0 mg, once daily

Lamivudine

Intervention Type DRUG

Oral, 100 mg, daily

Interventions

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Entecavir

Tablets, Oral, 1.0 mg, once daily

Intervention Type DRUG

Lamivudine

Oral, 100 mg, daily

Intervention Type DRUG

Other Intervention Names

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Baraclude

Eligibility Criteria

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Inclusion Criteria

* Age of 16 years and older
* Receipt of entecavir or lamivudine in a previous entecavir study.

Participants who were, based on their response to entecavir:

* Virologic nonresponders at Week 48
* Partial virologic responders who became nonresponders during the second year of treatment
* Partial virologic responders at Week 96
* Complete responders who relapsed during postdosing follow-up

* Decompensated liver disease in AI463-048 that met 1 or more of the following criteria:
* Nonresponse to adefovir after at least 24 weeks of treatment
* Partial response to adefovir after 96 weeks of treatment
* Complete response to adefovir after relapsing during postdosing follow-up
* Demonstrated intolerance to adefovir

* Except for those participants enrolled from AI463-048, compensated liver disease.

Exclusion Criteria

* HIV coinfection
* Receiving nephrotoxic or hepatotoxic agents
* Ongoing opportunistic infections
* Hemoglobin level \<11.0 g/dL except for those enrolled from AI463-048
* Platelet count \<70,000 mm\^3 except for those enrolled from AI463-048
* Absolute granulocyte count \<1,500 cells/mm\^3
* Recent history of pancreatitis (within 24 weeks prior to first dose of therapy)
* Current evidence of ascites requiring paracentesis, hepatic encephalopathy, or variceal bleeding, except for those enrolled from AI463-048
* Known history of allergy to nucleoside analogues.
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

References

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Manns MP, Akarca US, Chang TT, Sievert W, Yoon SK, Tsai N, Min A, Pangerl A, Beebe S, Yu M, Wongcharatrawee S. Long-term safety and tolerability of entecavir in patients with chronic hepatitis B in the rollover study ETV-901. Expert Opin Drug Saf. 2012 May;11(3):361-8. doi: 10.1517/14740338.2012.653340. Epub 2012 Jan 11.

Reference Type DERIVED
PMID: 22233350 (View on PubMed)

Other Identifiers

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AI463-901

Identifier Type: -

Identifier Source: org_study_id