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.
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 Type
OBSERVATIONAL
Enrollment
600
Wei Lai
Beijing, Beijing Municipality, China
RECRUITINGHCV RNA level
• HCV RNA level when on HCV treatments
Time frame: 5 years
Subjects ratio of cirrhosis, HCC and death
• Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options
Time frame: 5 years
Viral genotypes of subjects
Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime
Time frame: 5 years
Host genotypes of subjects
Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime
Time frame: 5 years
Diabetes status of subjects
Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime
Time frame: 5 years
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