Not provided
Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| CCgenos Follow-up phase | Other Identifier | EC of Peking University People's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCV Patients | 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). |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| HCV RNA level | • HCV RNA level when on HCV treatments | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects ratio of cirrhosis, HCC and death | • Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options | 5 years |
| Viral genotypes of subjects | Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
600
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lai Wei, Prof | Contact | weelai@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Hong Li, Ph.D | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wei Lai | Recruiting | Beijing | Beijing Municipality | 100044 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38200419 | Derived | Huang R, Shang J, Chen H, Li J, Xie Q, Feng J, Wei L, Rao H. Sustained virologic response improved the long-term health-related quality of life in patients with chronic hepatitis C: a prospective national study in China. BMC Infect Dis. 2024 Jan 10;24(1):72. doi: 10.1186/s12879-023-08940-3. | |
| 31934936 | Derived |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
Not provided
Not provided
Not provided
Not provided
Not provided
Samples with HCV RNA
| 5 years |
| Host genotypes of subjects | Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime | 5 years |
| Diabetes status of subjects | Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime | 5 years |
| Wu N, Rao HY, Yang WB, Gao ZL, Yang RF, Fei R, Gao YH, Jin Q, Wei L. Impact of hepatitis C virus genotype 3 on liver disease progression in a Chinese national cohort. Chin Med J (Engl). 2020 Feb 5;133(3):253-261. doi: 10.1097/CM9.0000000000000629. |
| 31566575 | Derived | Rao H, Xie Q, Shang J, Gao Z, Chen H, Sun Y, Jiang J, Niu J, Zhang L, Wang L, Zhao L, Li J, Yang R, Zhu S, Li R, Wei L. Real-world clinical outcomes among individuals with chronic HCV infection in China: CCgenos study. Antivir Ther. 2019;24(7):473-483. doi: 10.3851/IMP3334. |
| D014777 |
| Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |