A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
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| ClinicalTrials.gov Identifier: NCT01594554 |
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Recruitment Status : Unknown
Verified May 2012 by Lai Wei, Peking University People's Hospital.
Recruitment status was: Recruiting
First Posted : May 9, 2012
Last Update Posted : May 10, 2012
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Sponsor:
Peking University People's Hospital
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Lai Wei, Peking University People's Hospital
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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.
| Condition or disease |
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| Hepatitis C |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 600 participants |
| 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) |
| Study Start Date : | April 2012 |
| Estimated Primary Completion Date : | April 2016 |
| Estimated Study Completion Date : | September 2016 |
| Group/Cohort |
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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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Primary Outcome Measures :
- HCV RNA level [ Time Frame: 5 years ]• HCV RNA level when on HCV treatments
Secondary Outcome Measures :
- Subjects ratio of cirrhosis, HCC and death [ Time Frame: 5 years ]• Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options
- Viral genotypes of subjects [ Time Frame: 5 years ]Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime
- Host genotypes of subjects [ Time Frame: 5 years ]Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime
- Diabetes status of subjects [ Time Frame: 5 years ]Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime
Biospecimen Retention: Samples With DNA
Samples with HCV RNA
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
600
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01594554
Contacts
| Contact: Lai Wei, Prof | weelai@163.com |
Locations
| China, Beijing | |
| Wei Lai | Recruiting |
| Beijing, Beijing, China, 100044 | |
| Contact: Wei Lai, MD weelai@163.com | |
| Contact: Li Hong, Ph. D. | |
Sponsors and Collaborators
Peking University People's Hospital
Bristol-Myers Squibb
Investigators
| Study Director: | Hong Li, Ph.D | Bristol-Myers Squibb |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 |
| Other Study ID Numbers: |
AI452018 ST CCgenos Follow-up phase ( Other Identifier: EC of Peking University People's Hospital ) |
| First Posted: | May 9, 2012 Key Record Dates |
| Last Update Posted: | May 10, 2012 |
| Last Verified: | May 2012 |
Keywords provided by Lai Wei, Peking University People's Hospital:
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HCV viral genotypes host genotypes IL28B Outcome |
Follow-Up ITPA RNA China |
Additional relevant MeSH terms:
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Hepatitis C Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections |