Clinical trial NCT01594554: 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)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatitis C
Keywords: HCV viral genotypes
host genotypes
IL28B
Outcome
Follow-Up
ITPA
RNA
China
Lead sponsor: Peking University People's Hospital
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
First posted: 2012-05-09
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 600

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.

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

Primary outcomes:
measure: HCV RNA level
timeFrame: 5 years
Secondary outcomes:
measure: Subjects ratio of cirrhosis, HCC and death
timeFrame: 5 years
measure: Viral genotypes of subjects
timeFrame: 5 years
measure: Host genotypes of subjects
timeFrame: 5 years
measure: Diabetes status of subjects
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Wei Lai
state: Beijing
Study officials:
affiliation: Bristol-Myers Squibb
name: Hong Li, Ph.D
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.