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

Completed

• Conditions: Hepatitis C

• Registration Number: NCT01293279
• Lead Sponsor: Peking University People's Hospital

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-09
• Study First Submitted QC: 2011-02-09
• Study First Posted: 2011-02-10
• Status Verified: 2011-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Last Update Submitted: 2011-10-06
• Last Update Posted: 2011-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 997

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Lai Wei; 🇨🇳 Beijing, Beijing, China