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
  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
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

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 August 19, 2014