NCT01453244

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
373

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 13, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 17, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

June 3, 2013

Status Verified

May 1, 2013

Enrollment Period

1.7 years

First QC Date

October 13, 2011

Last Update Submit

May 30, 2013

Conditions

Chronic Hepatitis C

Keywords

Chronic hepatitis CPharmacogenomicsIL28BITPA

Outcome Measures

Primary Outcomes (1)

  • 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 (1)

  • Anemia

    4 weeks after start of treatment

Study Arms (2)

SVR group

A patients who achieved SVR (sustained virologic response)

non-SVR group

A patients who not achieved SVR (sustained virologic response)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Korean patients with chronic hepatitis C

You may qualify if:

  • Hepatitis C virus infected patients

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Inje University

Busan, 633-165, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA extracted from blood

MeSH Terms

Conditions

Hepatitis C, Chronic

Condition Hierarchy (Ancestors)

Hepatitis CBlood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jae-Gook Shin, M.D, phD

    Inje University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Jae-Gook Shin

Study Record Dates

First Submitted

October 13, 2011

First Posted

October 17, 2011

Study Start

July 1, 2011

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

June 3, 2013

Record last verified: 2013-05

Locations

KR(1)