A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

A 5-year study to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.

Condition or disease
Hepatitis C

Detailed Description:

A sample of 600 Han ethnic Chinese male or female who are ≥ 18 years old enrolled and completed in the study of AI452-009 (i.e., CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279). In the AI452-009 study, all patients had 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 (AI452-018, CCgenos follow up phase, ClinicalTrials.gov Identifier: NCT01293279) is to observe and describe long-term patient management and treatment patterns with associated outcomes of patients who previously enrolled in Protocol AI452009 (i.e., the CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279) and had their genotype characterized at diagnosis of HCV infection in a real world clinical practice in China.

Study Design

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Study Type :	Observational
Estimated Enrollment :	600 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	A 5-year Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Real World Clinical Practice for Patients of Newly Confirmed HCV Infection in China (2012-2016)
Study Start Date :	April 2012
Estimated Primary Completion Date :	April 2016
Estimated Study Completion Date :	September 2016

Groups and Cohorts

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Group/Cohort
HCV Patients; A sample of 600 Han ethnic Chinese male or female who are ≥ 18 years old enrolled and completed in the study of AI452-009 (i.e., CCgenos cross sectional phase, ClinicalTrials.gov Identifier: NCT01293279).

Outcome Measures

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Primary Outcome Measures :

1. HCV RNA level [ Time Frame: 5 years ]
   • HCV RNA level when on HCV treatments

Secondary Outcome Measures :

1. Subjects ratio of cirrhosis, HCC and death [ Time Frame: 5 years ]
   • Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options
2. Viral genotypes of subjects [ Time Frame: 5 years ]
   Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime
3. Host genotypes of subjects [ Time Frame: 5 years ]
   Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime
4. Diabetes status of subjects [ Time Frame: 5 years ]
   Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime

Biospecimen Retention:   Samples With DNA

Samples with HCV RNA

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

600

Criteria

Inclusion Criteria:

• None. Patients from AI452-009 study who accepted ICF to be follow up

Exclusion Criteria:

• < 18 years old not Han ethnic Not be willing to be followed up to 5 years

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Lai Wei, Prof		weelai@163.com

Locations

China, Beijing
Wei Lai	Recruiting
Beijing, Beijing, China, 100044
Contact: Wei Lai, MD weelai@163.com
Contact: Li Hong, Ph. D.

Sponsors and Collaborators

Peking University People's Hospital

Bristol-Myers Squibb

Investigators

Study Director:	Hong Li, Ph.D	Bristol-Myers Squibb

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Lai Wei, Director of Peking University Hepatology Institute at Peking University People's Hospital, Peking University People's Hospital
ClinicalTrials.gov Identifier:	NCT01594554 History of Changes
Other Study ID Numbers:	AI452018 ST; CCgenos Follow-up phase ( Other Identifier: EC of Peking University People's Hospital )
First Posted:	May 9, 2012
Last Update Posted:	May 10, 2012
Last Verified:	May 2012

Keywords provided by Lai Wei, Peking University People's Hospital:

HCV viral genotypes; host genotypes; IL28B; Outcome	Follow-Up; ITPA; RNA; China

Additional relevant MeSH terms:

Hepatitis C; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections	RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases