Systematic Review of Antiretroviral Treatments for Chroni... | NCT01155427

Studies
Systematic Review of Antiretroviral Treatments for Chronic Hepatitis B (CHB)

NCT01155427

Sponsor

Bristol-Myers Squibb

Status

Completed

Last Update Posted

Jul 1, 2010Estimated

Enrollment

100Actual

Phase

Not provided

Conditions

Hepatitis B, Chronic

Interventions

Not provided

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

Jun 2010

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 2009

Primary Completion Date

Apr 2010Actual

Completion Date

Apr 2010Actual

First Submitted Date

Jun 29, 2010

First Submission Date that Met QC Criteria

Jun 30, 2010

First Posted Date

Jul 1, 2010Estimated

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 30, 2010

Last Update Posted Date

Jul 1, 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 this study is to support the clinical value of entecavir by assessing the relationship between viral load and histological improvement.

Detailed Description

Systematic review of prospective clinical trials

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
entecavir		Patients initiating special antiviral treatments for CHB
tenofovir		Patients initiating special antiviral treatments for CHB
lamivudine		Patients initiating special antiviral treatments for CHB
telbivudine		Patients initiating special antiviral treatments for CHB
adefovir		Patients initiating special antiviral treatments for CHB

Interventions

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with CHB diagnosis and no co-infection with Hep A, Hep C, Hep D, or HIV
Age 16 years or older
No post-transplant patients
RCT, non-randomized trials, prospective cohort studies, prospectively analyses case series published since 2003
At least one arm of trial must include monotherapy with entecavir, lamivudine, tenofovir, adefovir, or telbivudine
Study arms must include at least 10 patients
Follow-up of at least 48 weeks
Published results available in English language

Exclusion Criteria:

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

Clinical trial enrollees

Sampling Method

Non-Probability Sample

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

References Module

Citations

Not provided

Measure	Description	Time Frame
Viral load
Histological improvement

Label	URL
BMS Clinical Trials Disclosure	View source
For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm	View source

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