Hepatitis C
Conditions
Keywords
HCV viral genotypes, host genotypes, IL28B, Outcome, Follow-Up, ITPA, RNA, China
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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Peking University People's Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HCV RNA level | 5 years | • HCV RNA level when on HCV treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Contacts
Primary ContactLai Wei, Prof
Outcome results
None listed