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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01293279
Acronym
HCV
Enrollment
997
Registered
2011-02-10
Start date
2011-02-28
Completion date
2011-06-30
Last updated
2011-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C

Keywords

HCV viral genotypes, host genotypes, IL28B, ITPA, RNA, China

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.

Interventions

None listed

Sponsors

Bristol-Myers Squibb
CollaboratorINDUSTRY
Peking University People's Hospital
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Hepatitis C viral and host genotypesConfirmation of an HCV infection 30 days prior to the recruitmentTo describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients

Secondary

MeasureTime frameDescription
Hepatitis C RNA levelsConfirmation of an HCV infection 30 days prior to the recruitmentTo describe the distribution of HCV RNA levels in antiviral treatment-naive HCV patients

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 6, 2026