3E Extension Study | NCT01834508

Studies
3E Extension Study

NCT01834508

Sponsor

Nanfang Hospital, Southern Medical University

Status

Unknown status

Last Update Posted

Jun 19, 2014Estimated

Enrollment

600Estimated

Phase

Phase 4

Conditions

Chronic Hepatitis B

Interventions

oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

Countries

China

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

Jun 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2013

Primary Completion Date

Jun 2016Estimated

Completion Date

Dec 2016Estimated

First Submitted Date

Apr 14, 2013

First Submission Date that Met QC Criteria

Apr 17, 2013

First Posted Date

Apr 18, 2013Estimated

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

Jun 17, 2014

Last Update Posted Date

Jun 19, 2014Estimated

Name	Class
Major Science and Technology Special Project of China 12th Five-year	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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 this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.

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

600Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Other		Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks

Interventions

Name	Type	Description	Arm Group Labels	Other Names
oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks	Drug		Treatment group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentages of patients achieving HBV DNA< 300copies/mL at week 144		Week 144

Secondary Outcomes

Measure	Description	Time Frame
Percentages of patients achieving HBV DNA <300copies/mL at week 48/96		Week 48 & 96
The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144		Week 48 & 96 &144

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study.
Subjects who are willing to participate the extension study.

Exclusion Criteria:

Subjects who could not compliance with the protocol judged by investigators

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
302 Military Hospital Of China		Beijing	Beijing Municipality		China
Beijing Ditan Hospita

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
C053001	adefovir

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided