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. The completion date has passed and the status has not been verified in more than two years.

Verified May 2012 by Lai Wei, Peking University People's Hospital.
Recruitment status was: Recruiting

Sponsor:

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

History of Changes

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 Lai Wei, Peking University People's Hospital:

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


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)
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

Contacts and Locations

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, see Learn About Clinical Studies.

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 ( Other Identifier: EC of Peking University People's Hospital )
Study First Received:	April 4, 2012
Last Updated:	May 8, 2012

Keywords provided by Lai Wei, 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 August 17, 2017

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