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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Hepatitis C

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HCV Patients<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA level | • HCV RNA level when on HCV treatments | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjects ratio of cirrhosis, HCC and death | • Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options | 5 years | 
| Viral genotypes of subjects | Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime | 5 years | 
| Host genotypes of subjects | Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime | 5 years | 
| Diabetes status of subjects | Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HCV viral genotypes, host genotypes, IL28B, Outcome, Follow-Up, ITPA, RNA, China