A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2012 by Peking University People's Hospital.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
Peking University People's Hospital
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Lai Wei, Peking University People's Hospital
ClinicalTrials.gov Identifier:
NCT01594554
First received: April 4, 2012
Last updated: May 8, 2012
Last verified: May 2012
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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 |
|---|
|
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) |
Further study details as provided by Peking University People's Hospital:
Primary Outcome Measures:
- HCV RNA level [ Time Frame: 5 years ] [ Designated as safety issue: No ]• HCV RNA level when on HCV treatments
Secondary Outcome Measures:
- 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).
|
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 (Adult, Senior) |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01594554
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
More Information
| 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:
|
Hepatitis C Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections |
RNA Virus Infections Hepatitis Liver Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016