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

This study has been terminated.

(Business Objectives Have Changed)

Sponsor:

Information provided by:

Bristol-Myers Squibb

ClinicalTrials.gov Identifier:

NCT00605384

First received: January 18, 2008

Last updated: November 15, 2010

Last verified: November 2010

History of Changes

Results First Received: July 13, 2010

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

Participant Flow

Hide Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 84 subjects were to be treated with entecavir (ETV) plus tenofovir (TNF) or adefovir (ADV) added to continuing lamivudine (LVD).

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of the 4 subjects enrolled, 2 were not randomized (reasons: “Subject no longer meets study criteria” and “Other”). Both subjects randomized were treated as well.

Reporting Groups

	Description
Entecavir + Tenofovir	Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
Adefovir + Continuing Lamivudine	Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks

Participant Flow: Overall Study

	Entecavir + Tenofovir	Adefovir + Continuing Lamivudine
STARTED	1	1
COMPLETED	0 ^[1]	0 ^[1]
NOT COMPLETED	1	1

[1]	study terminated early

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Entecavir + Tenofovir	Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
Adefovir + Continuing Lamivudine	Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
Total	Total of all reporting groups

Baseline Measures

	Entecavir + Tenofovir	Adefovir + Continuing Lamivudine	Total
Number of Participants [units: participants]	1	1	2
Age, Customized [units: participants]
Between 18 and 65 years	0	1	1
>=65 years	1	0	1
Gender [units: participants]
Female	1	0	1
Male	0	1	1

Outcome Measures

Show All Outcome Measures

1. Primary:

Number of Participants Who Achieved an Hepatitis B Virus DNA (HBV DNA) Level < 50 IU/mL at Week 48 [ Time Frame: Week 48 ]

Show Outcome Measure 1

2. Secondary:

Number of Participants Who Achieved an HBV DNA Level <50 IU/mL at Week 96 [ Time Frame: Week 96 ]

Show Outcome Measure 2

3. Secondary:

Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs or Laboratory Abnormalities [ Time Frame: Day 1 through end of treatment (Week 100 +/- 5 days) ]

Show Outcome Measure 3

4. Secondary:

Number of Participants Who Achieved HBV DNA < the Lower Limit of Detection (LLD) at Weeks 48 and 96 [ Time Frame: Week 48, Week 96 ]

Show Outcome Measure 4

5. Secondary:

HBV DNA Values at Weeks 48 and 96 [ Time Frame: Weeks 48, Week 96 ]

Show Outcome Measure 5

6. Secondary:

Mean log10 Reduction From Baseline in HBV DNA at Weeks 48 and 96 [ Time Frame: Week 48, Week 96 ]

Show Outcome Measure 6

7. Secondary:

Number of Participants With Alanine Aminotransferase (ALT) > 1 x Upper Limit of Normal (ULN) at Baseline Who Achieved ALT Normalization (≤ 1 x ULN) at Weeks 48 and 96 [ Time Frame: Week 48, Week 96 ]

Show Outcome Measure 7

8. Secondary:

Number of Participants Who Were Hepatitis B E-antigen (HBeAg)-Positive at Baseline With Loss of HBeAg at Weeks 48 and 96 [ Time Frame: Baseline, Week 48, Week 96 ]

Show Outcome Measure 8

9. Secondary:

Number of Participants Who Were HBeAg-positive at Baseline With HBe Seroconversion at Weeks 48 and 96 [ Time Frame: Baseline, Week 48, Week 96 ]

Show Outcome Measure 9

10. Secondary:

Number of Participants With Hepatitis-B-Virus Surface Antigen of the (HBsAg) Loss at Weeks 48 and 96 [ Time Frame: Week 48, Week 96 ]

Show Outcome Measure 10

11. Secondary:

Number of Participants With HBs Seroconversion (HBsAg Loss and Presence of HBsAb) at Weeks 48 and 96 [ Time Frame: Week 48, Week 96 ]

Show Outcome Measure 11

12. Secondary:

Number of Participants With Genotypic Resistance Based on Analysis of Samples From Participants With HBV DNA ≥ 50 IU/mL at Weeks 48 and 96 [ Time Frame: Week 48, Week 96 ]

Show Outcome Measure 12

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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
Following review of business priorities, BMS decided to terminate this study at an early stage. This was a strategic decision, not based on clinical or safety concerns. Due to limited data, no conclusions on safety and efficacy can be made.

Results Point of Contact:

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

No publications provided

Responsible Party:	Study Director, Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00605384 History of Changes
Other Study ID Numbers:	AI463-137
Study First Received:	January 18, 2008
Results First Received:	July 13, 2010
Last Updated:	November 15, 2010
Health Authority:	United States: Food and Drug Administration

To Top