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

Hepatitis C Clinical Trial

— HCV  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01293279
• Other study ID #: CCgenos
• Status: Completed
• Phase: N/A
• First received: February 9, 2011
• Last updated: October 6, 2011
• Start date: February 2011
• Est. completion date: June 2011

Study information

• Verified date: June 2011
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 997
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C

Locations

Country	Name	City	State
China	Lai Wei	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hepatitis C viral and host genotypes	To describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients	Confirmation of an HCV infection 30 days prior to the recruitment	No
Secondary	Hepatitis C RNA levels	To describe the distribution of HCV RNA levels in antiviral treatment-naive HCV patients	Confirmation of an HCV infection 30 days prior to the recruitment	No