A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
- Conditions
- Hepatitis C
- Registration Number
- NCT01594554
- Lead Sponsor
- Peking University People's Hospital
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 600
- None. Patients from AI452-009 study who accepted ICF to be follow up
- < 18 years old not Han ethnic Not be willing to be followed up to 5 years
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HCV RNA level 5 years • HCV RNA level when on HCV treatments
- Secondary Outcome Measures
Name Time Method Subjects ratio of cirrhosis, HCC and death 5 years • Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options
Viral genotypes of subjects 5 years Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime
Host genotypes of subjects 5 years Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime
Diabetes status of subjects 5 years Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime
Trial Locations
- Locations (1)
Wei Lai
🇨🇳Beijing, Beijing, China