Clinical trial NCT01293279: HCV (Hepatitis C Virus) Viral and Host Genotyping (IL28B, Interleukin 28B) in China
Official title: HCV Viral Genotyping Distribution and Genetic Variation in IL28B Distributions Among the Han Ethnic Chinese in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Keywords: HCV viral genotypes
host genotypes
IL28B
ITPA
RNA
China
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2011-02-10
Enrollment: 997
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1000 Han ethnic Chinese in 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.

Eligibility 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

Primary outcomes:
measure: Hepatitis C viral and host genotypes
timeFrame: Confirmation of an HCV infection 30 days prior to the recruitment
Secondary outcomes:
measure: Hepatitis C RNA levels
timeFrame: Confirmation of an HCV infection 30 days prior to the recruitment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Lai Wei
state: Beijing
Study officials:
affiliation: Peking University People's Hospital, Peking University Hepatology Institute
name: Lai Wei, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bristol-Myers Squibb
name: Hong Li, Ph.D., MPH
role: STUDY_DIRECTOR
References:
citation: Wu N, Rao HY, Yang WB, Gao ZL, Yang RF, Fei R, Gao YH, Jin Q, Wei L. Impact of hepatitis C virus genotype 3 on liver disease progression in a Chinese national cohort. Chin Med J (Engl). 2020 Feb 5;133(3):253-261. doi: 10.1097/CM9.0000000000000629.
citation: Huang R, Rao H, Shang J, Chen H, Li J, Xie Q, Gao Z, Wang L, Wei J, Jiang J, Sun J, Jiang J, Wei L. A cross-sectional assessment of health-related quality of life in Chinese patients with chronic hepatitis c virus infection with EQ-5D. Health Qual Life Outcomes. 2018 Jun 15;16(1):124. doi: 10.1186/s12955-018-0941-8.
citation: Yan LB, Rao HY, Ma YJ, Bai L, Chen EQ, Du LY, Yang RF, Wei L, Tang H; CCgenos Study Group. Hepatitis B virus infection in Chinese patients with hepatitis C virus infection: prevalence, clinical characteristics, viral interactions and host genotypes: a nationwide cross-sectional study. BMJ Open. 2016 Oct 12;6(10):e012016. doi: 10.1136/bmjopen-2016-012016.