Pharmacogenomic Research in Korean Patients With Hepatitis C | NCT01453244

Studies
Pharmacogenomic Research in Korean Patients With Hepatitis C

NCT01453244

Sponsor

Inje University

Status

Completed

Last Update Posted

Jun 3, 2013Estimated

Enrollment

373Actual

Phase

Not provided

Conditions

Chronic Hepatitis C

Interventions

Not provided

Countries

South Korea

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 2013

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

Jul 2011

Primary Completion Date

Mar 2013Actual

Completion Date

Mar 2013Actual

First Submitted Date

Oct 13, 2011

First Submission Date that Met QC Criteria

Oct 14, 2011

First Posted Date

Oct 17, 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

May 30, 2013

Last Update Posted Date

Jun 3, 2013Estimated

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 aim of this study is to investigate the relationships between drug response and the host genetic factors, viral factors and clinical factors in chronic hepatitis C patients (HCV). And thus, the investigators are trying to develop the pharmacogenomic guideline in the Korean patients with HCV.

Detailed Description

Not provided

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

373Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SVR group		A patients who achieved SVR (sustained virologic response)
non-SVR group		A patients who not achieved SVR (sustained virologic response)

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sustained virological response (SVR)	Undetectable HCV RNA in serum ( <15 IU/ml ) 24 weeks after the end of treatment	24 weeks after the end of treatment

Secondary Outcomes

Measure	Description	Time Frame
Anemia	a reduction in Hemoglobin of >3.0 g/dL a reduction in Hemoglobin levels to 10.0g/dL.	4 weeks after start of treatment

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hepatitis C virus infected patients

Exclusion Criteria:

Patients who infected Hepatitis B virus or Human immunodeficiency virus
HCV infected patients previously treated with antiviral drugs
Patients had a history of autoimmune hemolytic anemia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Korean patients with chronic hepatitis C

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jae-Gook Shin, M.D, phD	Inje University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Inje University		Busan		633-165	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D019698	Hepatitis C, Chronic

Ancestor Terms

ID	Term
D006526	Hepatitis C
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided