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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China|
- 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
- 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
|Study Start Date:||February 2011|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01293279
|Beijing, Beijing, China, 100044|
|Principal Investigator:||Lai Wei, MD||Peking University People's Hospital, Peking University Hepatology Institute|
|Study Director:||Hong Li, Ph.D., MPH||Bristol-Myers Squibb|