A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
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
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease |
---|
Hepatitis C |
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 |
---|
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).
|
- 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
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

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, 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 |
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 |
HCV viral genotypes host genotypes IL28B Outcome |
Follow-Up ITPA RNA China |
Hepatitis C Hepatitis Liver Diseases Digestive System Diseases |
Hepatitis, Viral, Human Virus Diseases Flaviviridae Infections RNA Virus Infections |