A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
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Purpose
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.
| Condition |
|---|
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Hepatitis C |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | A 5-year Observational Follow-up Study to Describe Treatment Patterns and Outcomes in Real World Clinical Practice for Patients of Newly Confirmed HCV Infection in China (2012-2016) |
- HCV RNA level [ Time Frame: 5 years ] [ Designated as safety issue: No ]• HCV RNA level when on HCV treatments
- Subjects ratio of cirrhosis, HCC and death [ Time Frame: 5 years ] [ Designated as safety issue: No ]• Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options
- Viral genotypes of subjects [ Time Frame: 5 years ] [ Designated as safety issue: No ]Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime
- Host genotypes of subjects [ Time Frame: 5 years ] [ Designated as safety issue: No ]Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime
- Diabetes status of subjects [ Time Frame: 5 years ] [ Designated as safety issue: No ]Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime
Biospecimen Retention: Samples With DNA
Samples with HCV RNA
| Estimated Enrollment: | 600 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | September 2016 |
| Estimated Primary Completion Date: | April 2016 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
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).
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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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
600
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
Contacts and Locations| Contact: Lai Wei, Prof | weelai@163.com |
| China, Beijing | |
| Wei Lai | Recruiting |
| Beijing, Beijing, China, 100044 | |
| Contact: Wei Lai, MD weelai@163.com | |
| Contact: Li Hong, Ph. D. | |
| Study Director: | Hong Li, Ph.D | Bristol-Myers Squibb |
More Information
No publications provided
| Responsible Party: | Lai Wei, Director of Peking University Hepatology Institute at Peking University People's Hospital, Peking University People's Hospital |
| ClinicalTrials.gov Identifier: | NCT01594554 History of Changes |
| Other Study ID Numbers: | AI452018 ST, CCgenos Follow-up phase |
| Study First Received: | April 4, 2012 |
| Last Updated: | May 8, 2012 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Peking University People's Hospital:
|
HCV viral genotypes host genotypes IL28B Outcome |
Follow-Up ITPA RNA China |
Additional relevant MeSH terms:
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Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections |
ClinicalTrials.gov processed this record on May 21, 2013