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

Hepatitis C Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01594554
• Other study ID #: AI452018 ST
• Secondary ID: CCgenos Follow-u
• Status: Recruiting
• Phase: N/A
• First received: April 4, 2012
• Last updated: May 8, 2012
• Start date: April 2012
• Est. completion date: September 2016

Study information

• Verified date: May 2012
• Source: Peking University People's Hospital
• Contact: Lai Wei, Prof
• Email: weelai[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: September 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hepatitis C

Locations

Country	Name	City	State
China	Wei Lai	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University People's Hospital	Bristol-Myers Squibb

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HCV RNA level	• HCV RNA level when on HCV treatments	5 years	No
Secondary	Subjects ratio of cirrhosis, HCC and death	• Evaluation of HCV disease progression (cirrhosis, HCC, death) over time regardless treatment options	5 years	No
Secondary	Viral genotypes of subjects	Evaluation of impacts of risk factors, such as viral genotypes on disease progression overtime	5 years	No
Secondary	Host genotypes of subjects	Evaluation of impacts of risk factors, such as host genotypes on disease progression overtime	5 years	No
Secondary	Diabetes status of subjects	Evaluation of impacts of risk factors, such as diabetes status on disease progression overtime	5 years	No