Efficacy of Peg-interferon α-2a in Hepatitis B Patients T... | NCT01599130

Studies
Efficacy of Peg-interferon α-2a in Hepatitis B Patients Treated by Entecavir Without HBeAg Loss

NCT01599130

Sponsor

Sun Yat-sen University

Status

Unknown status

Last Update Posted

May 15, 2012Estimated

Enrollment

60Estimated

Phase

Not Applicable

Conditions

Hepatitis B

Interventions

Entecavir
Peginterferon alfa-2a

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

May 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2012

Primary Completion Date

Apr 2014Estimated

Completion Date

Apr 2014Estimated

First Submitted Date

May 8, 2012

First Submission Date that Met QC Criteria

May 14, 2012

First Posted Date

May 15, 2012Estimated

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

May 14, 2012

Last Update Posted Date

May 15, 2012Estimated

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

For HBeAg (+) hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In the investigators study, patients were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

Detailed Description

For HBeAg positive hepatitis B patients who have been treated by entecavir for 48 weeks but without HBeAg loss, switching to peg-interferon may increase the response rate. In our study, patients without HBeAg loss to 48 weeks entecavir treatment were divided into two groups. In Group A, patients continued entecavir for another 72 weeks. In Group B, patients switched to peg-interferon-2a monotherapy for 48 weeks, then followed up 24 weeks.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
entecavir	Active Comparator	patients continue to use entecavir	Drug: Entecavir
peg-interferon	Experimental	patients switch to sequential peg-interferon α-2a	Drug: Peginterferon alfa-2a

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Entecavir	Drug	entecavir 0.5mg per day	entecavir	Baraclude

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HBeAg sericonversion rate		72 weeks

Secondary Outcomes

Measure	Description	Time Frame
HBeAg loss rate		72 weeks
HBeAg quantification dynamic change		72 weeks
HBsAg loss rate

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age between 18 and 50 years old
HBsAg(+) and HBeAg(+) for over 6 months before entecavir treatment
Treated by entacavir for 48 weeks with HBeAg seroconversion

Exclusion Criteria:

Pregnant women
Decompensated liver disease
Combination infection of HCV, HAV, or HEV
Combination infection of HIV
Any contraindication of interferon α

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Zhiliang Gao	The Third Affliated Hospital of Sun Yat-sen University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Third Affliated Hospital of Sun Yat-sen University		Guangzhou	Guangdong		China

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B

Ancestor Terms

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D018347	Hepadnaviridae Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C413685	entecavir
C100416	peginterferon alfa-2a

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided