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

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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
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Lai Wei, Peking University People's Hospital

Tracking Information
First Submitted Date April 4, 2012
First Posted Date May 9, 2012
Last Update Posted Date May 10, 2012
Study Start Date April 2012
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 8, 2012)
HCV RNA level [ Time Frame: 5 years ]
• HCV RNA level when on HCV treatments
Original Primary Outcome Measures
 (submitted: May 7, 2012)
HCV RNA level [ Time Frame: 5 years ]
  • HCV RNA level when on HCV treatments
  • Distributions of patients on HCV treatments and associated clinical outcomes overtime
Change History
Current Secondary Outcome Measures
 (submitted: May 7, 2012)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A 5-year Observational Follow-up Study to Describe Treatment Patterns in Real World of HCV Patients in China.
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)
Brief Summary 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.
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Samples with HCV RNA
Sampling Method Non-Probability Sample
Study Population 600
Condition Hepatitis C
Intervention Not Provided
Study 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: May 7, 2012)
600
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 2016
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01594554
Other Study ID Numbers AI452018 ST
CCgenos Follow-up phase ( Other Identifier: EC of Peking University People's Hospital )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Lai Wei, Peking University People's Hospital
Study Sponsor Peking University People's Hospital
Collaborators Bristol-Myers Squibb
Investigators
Study Director: Hong Li, Ph.D Bristol-Myers Squibb
PRS Account Peking University People's Hospital
Verification Date May 2012