Continue Entecavir Rollover From China | NCT00975091

Studies
Continue Entecavir Rollover From China

NCT00975091

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Feb 2, 2010Estimated

Enrollment

600Actual

Phase

Phase 3

Conditions

Chronic Hepatitis B Virus

Interventions

Entecavir
Entecavir

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2004

Primary Completion Date

Aug 2007Actual

Completion Date

Aug 2007Actual

First Submitted Date

Sep 8, 2009

First Submission Date that Met QC Criteria

Sep 10, 2009

First Posted Date

Sep 11, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Jan 29, 2010

Certification/Extension First Submitted that Passed QC Review

Jan 29, 2010

Certification/Extension First Posted Date

Feb 2, 2010Estimated

Last Update Submitted Date

Jan 29, 2010

Last Update Posted Date

Feb 2, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of the study is to determine if treatment with entecavir is safe and well tolerated in patients who completed dosing in a previous entecavir study in China, but are requiring further treatment of their chronic hepatitis B virus infection.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Entecavir 0.5	Active Comparator		Drug: Entecavir
Entecavir 1.0	Active Comparator		Drug: Entecavir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Entecavir	Drug	Tablets, Oral, 0.5 mg, once daily, Until ETV is commercially available in China or when Post Study Drug Program is started	Entecavir 0.5

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number and percentage of subjects with adverse events, laboratory abnormalities, and discontinuations due to adverse events		Through 3 years of dosing and up to 48 weeks of off treatment follow up

Secondary Outcomes

Measure	Description	Time Frame
The change in the mean HBV DNA measured by PCR assay from baseline for each entecavir cohort		Through 3 years of dosing

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who had completed the required dosing period in a previous ETV Phase 2 or 3 study in China (studies AI463012, AI463023, AI463056), and had been assessed by the Investigators as likely to benefit from additional therapy for treatment of their HBV infection
ALT ≤ 15 x upper limit of normal
Compensated liver disease

Exclusion Criteria:

Coinfection with HIV, HCV, or HDV

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

75 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bristol-Myers Squibb	Bristol-Myers Squibb	Study Director

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D019694	Hepatitis B, Chronic

Ancestor Terms

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C413685	entecavir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided