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

NCT01594554 | Unknown

• 2 other identifiers: AI452018 STCCgenos Follow-up phase
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

HCV viral genotypes; host genotypes; IL28B; Outcome; Follow-Up; ITPA; RNA; China

Outcome Measures

Primary Outcomes (1)

• HCV RNA level

  • HCV RNA level when on HCV treatments

  5 years

Secondary Outcomes (4)

• Subjects ratio of cirrhosis, HCC and death

  5 years

• Viral genotypes of subjects

  5 years

• Host genotypes of subjects

  5 years

• Diabetes status of subjects

  5 years

Study Arms (1)

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).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

600

You may qualify if:

• None. Patients from AI452-009 study who accepted ICF to be follow up

You may not qualify if:

• \< 18 years old not Han ethnic Not be willing to be followed up to 5 years

Sponsors & Collaborators

• Peking University People's Hospital: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

Wei Lai

Beijing, Beijing Municipality, 100044, China

RECRUITING

Related Publications (3)

• 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.

  PMID: 38200419 DERIVED

• 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.

  PMID: 31934936 DERIVED

• 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.

  PMID: 31566575 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Samples with HCV RNA

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Hong Li, Ph.D

  Bristol-Myers Squibb

  STUDY DIRECTOR

Central Study Contacts

Lai Wei, Prof

CONTACT

weelai@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Peking University Hepatology Institute at Peking University People's Hospital

Study Record Dates

• First Submitted: April 4, 2012
• First Posted: May 9, 2012
• Study Start: April 1, 2012
• Primary Completion: April 1, 2016
• Study Completion: September 1, 2016
• Last Updated: May 10, 2012

Record last verified: 2012-05

Locations

CN (1)