HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 997
- Locations
- 1
- Primary Endpoint
- Hepatitis C viral and host genotypes
Study Overview
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.
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
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Hepatitis C viral and host genotypes
Time Frame: 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 Outcomes
- Hepatitis C RNA levels(Confirmation of an HCV infection 30 days prior to the recruitment)
Investigators
Lai Wei
Professor
Peking University People's Hospital