NCT01293279

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
997

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2011

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 10, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 7, 2011

Status Verified

June 1, 2011

Enrollment Period

4 months

First QC Date

February 9, 2011

Last Update Submit

October 6, 2011

Conditions

Hepatitis C

Keywords

HCV viral genotypeshost genotypesIL28BITPARNAChina

Outcome Measures

Primary Outcomes (1)

  • Hepatitis C viral and host genotypes

    To describe the distributions of both HCV viral and host genotypes (IL28B and ITPA) among antiviral treatment naive HCV patients

    Confirmation of an HCV infection 30 days prior to the recruitment

Secondary Outcomes (1)

  • Hepatitis C RNA levels

    Confirmation of an HCV infection 30 days prior to the recruitment

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

1000 Han ethnic Chinese in China

You may qualify if:

  • 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

You may not qualify if:

  • \< 18 years old
  • not Han ethnic
  • treated by antiviral before this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lai Wei

Beijing, Beijing Municipality, 100044, China

Location

Related Publications (3)

  • 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.

    PMID: 31934936DERIVED

  • 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.

    PMID: 29903024DERIVED

  • 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.

    PMID: 27733412DERIVED

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

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepatitis, Viral, HumanVirus DiseasesFlaviviridae InfectionsRNA Virus InfectionsHepatitisLiver DiseasesDigestive System Diseases

Study Officials

  • Lai Wei, MD

    Peking University People's Hospital, Peking University Hepatology Institute

    PRINCIPAL INVESTIGATOR

  • Hong Li, Ph.D., MPH

    Bristol-Myers Squibb

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 9, 2011

First Posted

February 10, 2011

Study Start

February 1, 2011

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 7, 2011

Record last verified: 2011-06

Locations

CN(1)