A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
|ClinicalTrials.gov Identifier: NCT01594554|
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
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|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|
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).
- HCV RNA level [ Time Frame: 5 years ]• HCV RNA level when on HCV treatments
- 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
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
|Contact: Lai Wei, Proffirstname.lastname@example.org|
|Beijing, Beijing, China, 100044|
|Contact: Wei Lai, MD email@example.com|
|Contact: Li Hong, Ph. D.|
|Study Director:||Hong Li, Ph.D||Bristol-Myers Squibb|