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

• ClinicalTrials.gov Identifier: NCT01594554
• Recruitment Status: Unknown
• First Posted: May 9, 2012
• Last Update Posted: May 10, 2012
• Sponsor: Peking University People's Hospital
• 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

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 *

• Wu N, Rao HY, Yang WB, Gao ZL, Yang RF, Fei R, Gao YH, Jin Q, Wei L. Impact of hepatitis C virus genotype 3 on liver disease progression in a Chinese national cohort. Chin Med J (Engl). 2020 Feb 5;133(3):253-261. doi: 10.1097/CM9.0000000000000629.
• Rao H, Xie Q, Shang J, Gao Z, Chen H, Sun Y, Jiang J, Niu J, Zhang L, Wang L, Zhao L, Li J, Yang R, Zhu S, Li R, Wei L. Real-world clinical outcomes among individuals with chronic HCV infection in China: CCgenos study. Antivir Ther. 2019;24(7):473-483. doi: 10.3851/IMP3334.

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

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