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

NCT ID: NCT01293279

Last Updated: 2011-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

997 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-02-28

Study Completion Date

2011-06-30

Brief Summary

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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

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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.

Conditions

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Hepatitis C

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Peking University People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Lai Wei

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lai Wei, MD

Role: PRINCIPAL_INVESTIGATOR

Peking University People's Hospital, Peking University Hepatology Institute

Hong Li, Ph.D., MPH

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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Lai Wei

Beijing, Beijing Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 31934936 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29903024 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27733412 (View on PubMed)

Other Identifiers

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CCgenos

Identifier Type: -

Identifier Source: org_study_id