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Completed

NCT Number: NCT01293279

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

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.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Lai Wei

Beijing, Beijing Municipality, 100044, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. Hepatitis C RNA levels

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

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

Acronym: HCV

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Feb 10, 2011
Registry last updated
Oct 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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