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.
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
  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)

Resource links provided by NLM:


Further study details as provided by Peking University People's Hospital:

Primary Outcome Measures:
  • HCV RNA level [ Time Frame: 5 years ] [ Designated as safety issue: No ]
    • HCV RNA level when on HCV treatments


Secondary Outcome Measures:
  • 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


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
Genders Eligible for Study:   Both
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
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

No publications provided

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
Study First Received: April 4, 2012
Last Updated: May 8, 2012
Health Authority: China: Ministry of Health

Keywords provided by Peking University People's Hospital:
HCV viral genotypes
host genotypes
IL28B
Outcome
Follow-Up
ITPA
RNA
China

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on April 14, 2014