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

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Lai Wei, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01293279
First received: February 9, 2011
Last updated: October 6, 2011
Last verified: June 2011

February 9, 2011
October 6, 2011
February 2011
June 2011   (final data collection date for primary outcome measure)
Hepatitis C viral and host genotypes [ Time Frame: Confirmation of an HCV infection 30 days prior to the recruitment ] [ Designated as safety issue: No ]
To describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients
Same as current
Complete list of historical versions of study NCT01293279 on ClinicalTrials.gov Archive Site
Hepatitis C RNA levels [ Time Frame: Confirmation of an HCV infection 30 days prior to the recruitment ] [ Designated as safety issue: No ]
To describe the distribution of HCV RNA levels in antiviral treatment-naive HCV patients
Same as current
Not Provided
Not Provided
 
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

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.

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.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

By having the approvals from the EC and China National Human Genetic Resource Management Office (under China Ministry of Health) and having the patient informed consent, blood samples of all recruited patients will be retained under the proper conditions in Peking University People's Hospital, Beijing, China

Probability Sample

1000 Han ethnic Chinese in China

Hepatitis C
Not Provided
HCV Patients who are treatment naive
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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
997
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01293279
CCgenos
Yes
Lai Wei, Peking University People's Hospital
Peking University People's Hospital
Bristol-Myers Squibb
Principal Investigator: Lai Wei, MD Peking University People's Hospital, Peking University Hepatology Institute
Study Director: Hong Li, Ph.D., MPH Bristol-Myers Squibb
Peking University People's Hospital
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP