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| Name | Class |
|---|---|
| Beijing 302 Hospital | OTHER |
| Nanfang Hospital, Southern Medical University | OTHER |
| Yamanashi Prefectural Central Hospital | UNKNOWN |
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The study is designed to provide long term clinical and virologic follow up in subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy. This long term follow up study is observational and no treatment is provided for HCV infection.
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| Measure | Description | Time Frame |
|---|---|---|
| Sustained virological response (SVR) | The primary outcome measure is the occurence (yes or no) of sustained virologic response (SVR), defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) in serum at least 3 months after stopping therapy. Point estimates and confidence intervals will be calculated to describe the frequency of SVR in various patients receiving IFN or DAAs based treatment. | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment persistence | Treatment persistence will be the duration of treatment measured from the first dose of medication until treatment is discontinued. Reasons for premature discontinuation of treatment will be recorded. | 36 months |
| Virological breakthrough |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects infected with hepatitis C virus (HCV) who received interferon-based therapy or direct-acting antiviral agents (DAAs)-based therapy.
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| Name | Affiliation | Role |
|---|---|---|
| George Lau, MD | Humanity & Health Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Liver Fibrosis Diagnosis and Treatment Centre, 302 Hospital | Beijing | Beijing Municipality | 100039 | China | ||
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Serum/Plasma
The occurrence of virological breakthrough defined as an increase of HCV RNA by at least 1-log over nadir or to >100 IU if previously undetectable. |
| 36 months |
| Liver disease progression | Liver disease progression is a composite endpoint measured by laboratory parameters (alanine aminotransferase (ALT), aspartate aminotransferase (AST), bilirubin, albumin, platelets, prothrombin time (PT) and α-fetoprotein) and observed or reported clinical signs and symptoms. | Post treatment 10 years |
| Proportion of participants who develop hepatocellular carcinoma (HCC) through Year 10 by treatment regimen | Post treatment 5 years |
| Humanity and Health GI and Liver Centre |
| Hong Kong |
| Hong Kong |
| 00852 |
| China |
| Yamanashi Prefectural Central Hospital | Kofu | Yamanashi | 400-8506 | Japan |