Prospective Observational Study of Disease Progression in Chronic Hepatitis C

Observational Study of Disease Progression and Risk Factors in Chronic Hepatitis C Caused by Plasma Donation

The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.

Study Overview

• Status: Active, not recruiting
• Conditions: Liver Cirrhosis; Disease Progression; Hepatitis C, Chronic

• Study Type: Observational
• Enrollment (Actual): 133

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The plasma donors were primarily chosen from healthy farmers and agricultural workers living in a remote small city in the Northwest China.

Description

Inclusion Criteria:

• All these patients had a definite history of regular plasma donations with repeated blood cell re-transfusions.
• The Hepatitis C Virus antibody was positive.
• All patients did not receive interferon therapy before being recruited.

Exclusion Criteria:

• Patients with evidences for other forms of liver diseases.
• The coinfection with hepatitis B virus or other virus.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Healthy volunteers
Chronic hepatitis C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Fibrosis progression rate	20 years
The incidence of cirrhosis	20 years
Risk factors for the occurrence of cirrhosis	20 years

Secondary Outcome Measures

Outcome Measure	Time Frame
The incidence of hepatocellular carcinoma	20 years
Number of participants with chronic hepatitis C-related complications	20 years

Collaborators and Investigators

• Sponsor: Beijing YouAn Hospital
• Investigators: Principal Investigator: Zhongping Duan, Ph.D.,M.D., Beijing YouAn Hospital

Publications and helpful links

General Publications

• Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. doi: 10.1053/jhep.2002.36806.
• Poynard T, Bedossa P, Opolon P. Natural history of liver fibrosis progression in patients with chronic hepatitis C. The OBSVIRC, METAVIR, CLINIVIR, and DOSVIRC groups. Lancet. 1997 Mar 22;349(9055):825-32. doi: 10.1016/s0140-6736(96)07642-8.
• Ghany MG, Kleiner DE, Alter H, Doo E, Khokar F, Promrat K, Herion D, Park Y, Liang TJ, Hoofnagle JH. Progression of fibrosis in chronic hepatitis C. Gastroenterology. 2003 Jan;124(1):97-104. doi: 10.1053/gast.2003.50018.
• Seeff LB, Miller RN, Rabkin CS, Buskell-Bales Z, Straley-Eason KD, Smoak BL, Johnson LD, Lee SR, Kaplan EL. 45-year follow-up of hepatitis C virus infection in healthy young adults. Ann Intern Med. 2000 Jan 18;132(2):105-11. doi: 10.7326/0003-4819-132-2-200001180-00003.

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): June 1, 2011
• Study Completion (Anticipated): July 1, 2030

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: December 10, 2013
• First Posted (Estimate): December 16, 2013

Study Record Updates

• Last Update Posted (Estimate): December 17, 2013
• Last Update Submitted That Met QC Criteria: December 13, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Disease Attributes; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; Hepatitis, Chronic; Fibrosis; Disease Progression; Hepatitis; Hepatitis A; Hepatitis C; Liver Cirrhosis; Hepatitis C, Chronic
• Other Study ID Numbers: BJYAH-2011-045