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

Peking University

Status: Unknown

Conditions: Hepatitis C

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT01594554

CCgenos Follow-up phase (Other Identifier)

AI452018 ST

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

600 participants in 1 patient group

HCV Patients

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).