Entecavir Plus Adefovir in Lamivudine-Resistant Patients | NCT00986778

Studies
Entecavir Plus Adefovir in Lamivudine-Resistant Patients

NCT00986778

Sponsor

Bristol-Myers Squibb

Status

Withdrawn

Last Update Posted

Sep 1, 2015Estimated

Enrollment

0Actual

Phase

Phase 4

Conditions

Hepatitis B, Chronic

Interventions

Lamivudine
Entecavir
Adefovir

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

Dec 2009

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Business Objectives Changed

Expanded Access Info

Start Date

Dec 2009

Primary Completion Date

Dec 2012Estimated

Completion Date

Jun 2014Estimated

First Submitted Date

Sep 29, 2009

First Submission Date that Met QC Criteria

Sep 29, 2009

First Posted Date

Sep 30, 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

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 31, 2015

Last Update Posted Date

Sep 1, 2015Estimated

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

Combination therapy with entecavir 1.0 mg plus adefovir 10 mg has superior antiviral activity compared with either entecavir monotherapy 1.0 mg or adefovir 10 mg plus lamivudine 100 mg in Chinese adults with lamivudine-resistant chronic hepatitis B 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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Lamivudine plus Adefovir	Active Comparator	Drug: Lamivudine Drug: Adefovir
Entecavir	Active Comparator	Drug: Entecavir
Entecavir plus Adefovir	Experimental	Drug: Entecavir Drug: Adefovir

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lamivudine	Drug	Tablets, Oral, 100mg, once daily, 48-96 weeks depending on response	Lamivudine plus Adefovir

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The proportion of patients with HBV DNA < 50 IU/mL at W48		Week 48

Secondary Outcomes

Measure	Description	Time Frame
The proportion of patient with HBV DNA < 50 IU/mL at W 96		Week 96
Mean reduction of HBV DNA at W 48 & 96		Week 48 and 96
The proportion of subjects with ALT normalization at W 48 & 96

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CHB HBeAg(+) Subject with Lamivudine treatment history must have LVDr substitution at rtM204V/I
Naïve to nucleoside/nucleotide analogues except for LVD
HBV DNA > 17,200 IU/mL
Compensated liver function
Serum ALT <10 × ULN

Exclusion Criteria:

Women who are pregnant or breastfeeding
Evidence of decompensated cirrhosis
Coinfection with HIV, hepatitis C virus (HCV), or hepatitis D virus (HDV)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

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

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
D019259	Lamivudine
C413685	entecavir
C053001	adefovir
C106812	adefovir dipivoxil

Ancestor Terms

ID	Term
D016047	Zalcitabine
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided