A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2012 by Peking University People's Hospital
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

April 4, 2012
May 8, 2012
April 2012
April 2016   (final data collection date for primary outcome measure)
HCV RNA level [ Time Frame: 5 years ] [ Designated as safety issue: No ]
• HCV RNA level when on HCV treatments
HCV RNA level [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • HCV RNA level when on HCV treatments
  • Distributions of patients on HCV treatments and associated clinical outcomes overtime
Complete list of historical versions of study NCT01594554 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
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)

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Samples with HCV RNA

Non-Probability Sample

600

Hepatitis C
Not Provided
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).
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
600
September 2016
April 2016   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Lai Wei, Prof weelai@163.com
China
 
NCT01594554
AI452018 ST, CCgenos Follow-up phase
No
Lai Wei, Peking University People's Hospital
Peking University People's Hospital
Bristol-Myers Squibb
Study Director: Hong Li, Ph.D Bristol-Myers Squibb
Peking University People's Hospital
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP