HCV (Hepatitis C Virus) Viral and Host Genotyping (IL28B, Interleukin 28B) in China

Sponsor

Peking University People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01293279

Collaborator

Bristol-Myers Squibb (Industry)

997

Enrollment

Location

3.9

Duration (Months)

252.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The primary objective of this study is to estimate the distributions of HCV viral/human genotypes (including IL28B and inosine triphosphatase, ITPA), and HCV RNA level among ITPA gene among 1000 Han ethnic Chinese patients with HCV who are antiviral treatment naive at the time the study is conducted.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C

Detailed Description

A sample of 1000 Han ethnic Chinese male or female who are ≥ 18 years old with a recent confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral treatment naive from 28 university affiliated hospital in China. The primary objective of this study is to estimate the distributions of HCV Viral genotyping(ie, genotype 1 through 6 and their known subtypes), and host genotypes, both inosine triphosphatase (ITPA) gene, and IL28B. This study also collects other data including patients' demographic and clinical characteristics. There is no active antiviral treatments and no follow-up in this study.

Study Design

Study Type:

Observational

Anticipated Enrollment :

997 participants

Time Perspective:

Prospective

Official Title:

HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
HCV Patients who are treatment naive Han ethnic Chinese male or female ≥ 18 years old with recent a confirmation of anti-HCV-antibody positive and HCV RNA positive but antiviral or interferon treatment naive at the time this study starts from 28 university affiliated hospital throughout China.

Outcome Measures

Primary Outcome Measures

Hepatitis C viral and host genotypes [Confirmation of an HCV infection 30 days prior to the recruitment]
To describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients

Secondary Outcome Measures

Hepatitis C RNA levels [Confirmation of an HCV infection 30 days prior to the recruitment]
To describe the distribution of HCV RNA levels in antiviral treatment-naive HCV patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

male or female
Han ethnic
≥ 18 years old
recent confirmation of anti-HCV-antibody positive and HCV RNA positive 30 days prior to the recruitment
antiviral or interferon treatment naive

Exclusion Criteria:

< 18 years old
not Han ethnic
treated by antiviral before this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lai Wei	Beijing	Beijing	China	100044

Sponsors and Collaborators

Peking University People's Hospital
Bristol-Myers Squibb

Investigators

Principal Investigator: Lai Wei, MD, Peking University People's Hospital, Peking University Hepatology Institute
Study Director: Hong Li, Ph.D., MPH, Bristol-Myers Squibb