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

NCT ID: NCT01594554

Last Updated: 2012-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 600 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2016-09-30

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.

Conditions

Hepatitis C

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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).

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Peking University People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lai Wei

Director of Peking University Hepatology Institute at Peking University People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hong Li, Ph.D

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Wei Lai

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lai Wei, Prof

Role: CONTACT

weelai@163.com

Facility Contacts

Wei Lai, MD

Role: primary

weelai@163.com

Li Hong, Ph. D.

Role: backup

References

Huang R, Shang J, Chen H, Li J, Xie Q, Feng J, Wei L, Rao H. Sustained virologic response improved the long-term health-related quality of life in patients with chronic hepatitis C: a prospective national study in China. BMC Infect Dis. 2024 Jan 10;24(1):72. doi: 10.1186/s12879-023-08940-3.

Reference Type: DERIVED

PMID: 38200419 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31934936 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31566575 (View on PubMed)

Other Identifiers

CCgenos Follow-up phase

Identifier Type: OTHER

Identifier Source: secondary_id

AI452018 ST

Identifier Type: -

Identifier Source: org_study_id