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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
History of Changes
  Purpose

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.


Condition
Hepatitis C

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Biospecimen Retention:   Samples With DNA

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


Estimated Enrollment: 997
Study Start Date: February 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

1000 Han ethnic Chinese in China

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293279

Locations
China, Beijing
Lai Wei
Beijing, Beijing, China, 100044
Sponsors and Collaborators
Peking University People's Hospital
Bristol-Myers Squibb
Investigators
Principal Investigator: Lai Wei, MD Peking University People's Hospital, Peking University Hepatology Institute
Study Director: Hong Li, Ph.D., MPH Bristol-Myers Squibb
  More Information

No publications provided

Responsible Party: Lai Wei, Professor, Peking University People's Hospital
ClinicalTrials.gov Identifier: NCT01293279     History of Changes
Other Study ID Numbers: CCgenos
Study First Received: February 9, 2011
Last Updated: October 6, 2011
Health Authority: China: Ministry of Health

Keywords provided by Peking University People's Hospital:
HCV viral genotypes
host genotypes
IL28B
 ITPA
RNA
China

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 16, 2013