Investigation of the Immuno-regulation and Viral Hepatiti... | NCT00688389

Studies
Investigation of the Immuno-regulation and Viral Hepatitis Among Patients With or After Dengue Fever Infection

NCT00688389

Sponsor

Kaohsiung Medical University Chung-Ho Memorial Hospital

Status

Unknown status

Last Update Posted

Feb 28, 2019Actual

Enrollment

700Estimated

Phase

Not provided

Conditions

Dengue Fever

Interventions

case/control

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

ID	Type	Description	Link
CB9615

Status Module

Record Verification Date

Feb 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

May 28, 2008

First Submission Date that Met QC Criteria

May 30, 2008

First Posted Date

Jun 2, 2008Estimated

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

Feb 27, 2019

Last Update Posted Date

Feb 28, 2019Actual

Name	Class
Centers for Disease Control and Prevention	FED

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 study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.

Detailed Description

Research has showed that CLEC5A interacts with dengue virion directly, and is responsible for dengue virus (DV)-induced DAP12 phosphorylation. Data suggests that CLEC5A is a potential therapeutic target for dengue hemorrhagic fever (DHF)/dengue shock syndrome (DSS). This project will study the genes of CLEC5A, Mannose receptor, DC-SIGN, NALP, decoy receptor 3 (DcR3), Toll-like receptors(TLRs), and (Nod)-like receptors (NLRs) for both DF and DHF groups. In addition, serum level of decoy receptor 3 (DcR3) will be tested. The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.

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

700Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
healthy			Other: case/control
DF			Other: case/control
DHF			Other: case/control

Interventions

Name	Type	Description	Arm Group Labels	Other Names
case/control	Other	case: infected dengue fever people control:healthy people	DF DHF healthy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致	抽血20 c.c 檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致	2007/7/1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Clinical diagnosis of Dengue fever

Exclusion Criteria:

none

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

The samples are obtained from the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jih-Jin Tsai, MD	Contact	886-7-312-1101	5677	jijits@cc.kmu.edu.tw

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kaoshing Medical University Chung-Ho Memorial Hospital	Recruiting	Kaohsiung City			Taiwan

Condition Browse Module

MeSH Terms

ID	Term
D003715	Dengue

Ancestor Terms

ID	Term
D000096724	Mosquito-Borne Diseases
D000079426	Vector Borne Diseases
D007239	Infections
D001102	Arbovirus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D016022	Case-Control Studies

Ancestor Terms

ID	Term
D016021	Epidemiologic Studies
D016020	Epidemiologic Study Characteristics
D004812	Epidemiologic Methods
D008919	Investigative Techniques

Browse Leaves

Not provided

Browse Branches

Not provided