Effect of Antiviral Therapy on Host Immune in Patients Wi... | NCT01480492

Studies
Effect of Antiviral Therapy on Host Immune in Patients With Chronic Hepatitis B Virus(HBV) Infection

NCT01480492

Sponsor

Cz Li

Status

Completed

Last Update Posted

Nov 29, 2011Estimated

Enrollment

56Actual

Phase

Not Applicable

Conditions

HBeAg Positive Chronic Hepatitis B Infection

Interventions

Telbivudine

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

ID	Type	Description	Link
09zr400500	Other Grant/Funding Number	Shanghai Natural Science Fund
30972600	Other Grant/Funding Number	National Natural Science Foundation of China

Status Module

Record Verification Date

Nov 2011

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

Jan 2010

Primary Completion Date

Oct 2011Actual

Completion Date

Oct 2011Actual

First Submitted Date

Nov 15, 2011

First Submission Date that Met QC Criteria

Nov 28, 2011

First Posted Date

Nov 29, 2011Estimated

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

Nov 28, 2011

Last Update Posted Date

Nov 29, 2011Estimated

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

During hepatitis B virus(HBV) infection host immune plays important role.Recently there are many different antiviral therapy methods.Different antiviral therapy methods showed different effector.In order to investigate whether these antiviral therapy methods especially methods directly inhibit viral replication have some effect on host immune the investigators designed these study. The investigators want to observe the change of host immune during antiviral therapy in patients with chronic HBV infection, and analyze the relationship between these changes and the antiviral effector of these drugs.

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

56Actual

Label	Type	Description	Intervention Names
therapy	No Intervention		Drug: Telbivudine

Name	Type	Description	Arm Group Labels	Other Names
Telbivudine	Drug	600mg,1/d,one year	therapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change of programmed death-1(PD-1) level of patients with chronic HBV infection during therapy		base line-4 weeks-12 weeks-24 weeks-end of therapy

Secondary Outcomes

Measure	Description	Time Frame
Decline of hepatitis B e antigen (HBeAg) level		base line-4weeks-12weeks-24weeks-end of therapy

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

inclusion criteria:

18-65 years old
chronic HBV infection
HBeAg positive,HBV DNA more than 10E5 IU/mL
ALT ≥2×UTL

exclusion criteria:

with liver cancer
with liver failure
pregnant

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

66 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wan Mo Bin, Professor	Changhai Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Changhai Hospital		Shanghai	Shanghai Municipality	200433	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25071343	Derived	Li CZ, Hu JJ, Xue JY, Yin W, Liu YY, Fan WH, Xu H, Liang XS. Viral infection parameters not nucleoside analogue itself correlates with host immunity in nucleoside analogue therapy for chronic hepatitis B. World J Gastroenterol. 2014 Jul 28;20(28):9486-96. doi: 10.3748/wjg.v20.i28.9486.

ID	Term
D013936	Thymidine
D011741	Pyrimidine Nucleosides
D011743	Pyrimidines
D006573	Heterocyclic Compounds, 1-Ring