Suboptimal Responders to Adefovir Switching to Entecavir

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00718887

First received: July 17, 2008

Last updated: January 4, 2013

Last verified: January 2013

History of Changes

Results First Received: October 17, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Crossover Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Hepatitis B, Chronic
Interventions:	Drug: Entecavir Drug: Adefovir/Entecavir

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 228 participants were enrolled, of which 169 were randomized. A total of 166 participants received treatment.

Reporting Groups

	Description
Entecavir, 0.5 mg QD	Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
Adefovir, 10 mg QD/Entecavir, 0.5 mg QD	Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.

Participant Flow: Overall Study

	Entecavir, 0.5 mg QD	Adefovir, 10 mg QD/Entecavir, 0.5 mg QD
STARTED	89 ^[1]	77 ^[1]
COMPLETED	84 ^[2]	68
NOT COMPLETED	5	9
Withdrawal by Subject	3	2
Not identified	2	7

[1]	Participants who received treatment.
[2]	Continued in study after 48 weeks

Baseline Characteristics

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Reporting Groups

	Description
Entecavir, 0.5 mg QD	Participants with a pervious suboptimal response to adefovir received entecavir, 0.5 mg once daily (QD), for a maximum of 52 weeks.
Adefovir, 10 mg QD/Entecavir, 0.5 mg QD	Participants with a previous suboptimal response to adefovir received adefovir, 10 mg QD, for 12 weeks. At 12 weeks, participants were switched to entecavir, 0.5 mg QD, for a maximum of 40 weeks.
Total	Total of all reporting groups

Baseline Measures

	Entecavir, 0.5 mg QD	Adefovir, 10 mg QD/Entecavir, 0.5 mg QD	Total
Number of Participants [units: participants]	89	77	166
Age [units: Years] Median ( Full Range )	32.6 ( 16.9 to 62.4 )	34.1 ( 18.9 to 63.1 )	33.4 ( 16.9 to 63.1 )
Gender [units: participants]
Female	14	10	24
Male	75	67	142
Race/Ethnicity, Customized [units: Participants]
Asian	89	77	166
Other	0	0	0

Outcome Measures

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1. Primary:

Percentage of Participants Who Achieved a Hepatitis B Virus (HBV) DNA Level <50 IU/mL at Week 12 by Polymerase Chain Reaction Testing [ Time Frame: At Week 12 from Day 1 ]

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2. Secondary:

Percentage of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 48 by Polymerase Chain Reaction Testing [ Time Frame: At Week 48 from Day 1 ]

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3. Secondary:

Mean log10 Reduction From Baseline in Serum HBV DNA Level by Polymerase Chain Reaction Testing [ Time Frame: At Weeks 12 and 48 from Day 1 ]

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4. Secondary:

Percentage of Participants Who Achieved Normalization of Alanine Aminotransferase (ALT) [ Time Frame: At Weeks 12 and 48 from Day 1 ]

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5. Secondary:

Percentage of Participants With Loss of Hepatitis B e Antigen (HBeAg) and Hepatitis B e (HBe) Seroconversion [ Time Frame: At Weeks 12 and 48 from Day 1 ]

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6. Secondary:

Number of Participants With Hepatitis B s Surface Antibody (HBsAG) Loss and HBsAG Seroconversion [ Time Frame: At Weeks 12 and 48 from Day 1 ]

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7. Secondary:

Number of Participants With Genotypic Resistance to Entecavir [ Time Frame: At Week 48 from Day 1 ]

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8. Secondary:

Number of Participants With Adverse Events, Treatment-related AEs, Serious Adverse Events (SAEs), Treatment-related SAEs, Death as Outcome, Discontinuations Due to AEs, and Abnormalities in Laboratory Test Results (LTR) Leading to Discontinuation [ Time Frame: Continually from Day 1 through Week 48, and through 24-week follow-up period ]

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9. Secondary:

Percentage of Participants With Grade 3 or 4 Abnormalities in Laboratory Test Results [ Time Frame: Day 1 through Week 48 ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: BMS Study Director
Organization: Bristol-Myers Squibb
e-mail: Clinical.Trials@bms.com

No publications provided

Responsible Party:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00718887 History of Changes
Other Study ID Numbers:	AI463-171
Study First Received:	July 17, 2008
Results First Received:	October 17, 2012
Last Updated:	January 4, 2013
Health Authority:	China: Food and Drug Administration

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