Investigation of Hepatitis B and Hepatitis C in Taiwan | NCT00946010

Studies
Investigation of Hepatitis B and Hepatitis C in Taiwan

NCT00946010

Sponsor

National Taiwan University Hospital

Status

Completed

Last Update Posted

Jan 24, 2011Estimated

Enrollment

6,228Actual

Phase

Not provided

Conditions

Hepatitis B
Hepatitis C

Interventions

blood sampling and abdominal sonography

Countries

Taiwan

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

Jan 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

Apr 2008

Primary Completion Date

Aug 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Apr 1, 2008

First Submission Date that Met QC Criteria

Jul 23, 2009

First Posted Date

Jul 24, 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

Jan 20, 2011

Last Update Posted Date

Jan 24, 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

The purpose of this study is to investigate the differences of genotypes of hepatitis B and hepatitis C in Taiwan.

Detailed Description

The purpose of this study is investigating the differences of genotypes and DNA level or RNA level of hepatitis B and hepatitis C in Taiwan.

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

Retention

Enrollment

6,228Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Click here for more information about this study: Investigation of Hepatitis B and Hepatitis C in Taiwan	Biological: blood sampling and abdominal sonography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
blood sampling and abdominal sonography	Biological	10cc blood sampling and abdominal sonography	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
genotype and DNA level or RNA level of HBV and HCV virus		once during Mar. 2008- Jan. 2011

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Born before 1985/01/01
HBV or HCV carriers

Exclusion Criteria:

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

23 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

People Born before 1985/01/01 who live in Taiwan are HBV or HCV pateints.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jin-Chuan Sheu, M.D. P.H.D.	National Taiwan University Hospital	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Taiwan University Hospital		Taipei		100	Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D006509	Hepatitis B
D006526	Hepatitis C

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
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided