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)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatitis C
- Sponsor
- Peking University People's Hospital
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- HCV RNA level
- Last Updated
- 13 years ago
Overview
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.
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.
Investigators
Lai Wei
Director of Peking University Hepatology Institute at Peking University People's Hospital
Peking University People's Hospital
Eligibility 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
Outcomes
Primary Outcomes
HCV RNA level
Time Frame: 5 years
• HCV RNA level when on HCV treatments
Secondary Outcomes
- Subjects ratio of cirrhosis, HCC and death(5 years)
- Viral genotypes of subjects(5 years)
- Host genotypes of subjects(5 years)
- Diabetes status of subjects(5 years)