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

Peking University

Status: Completed

Conditions: Hepatitis C

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01293279

CCgenos

Details and patient eligibility

About

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.

Full 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.

Enrollment: 997 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

997 participants in 1 patient group

HCV Patients who are treatment naive

Description:

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.