Prospective Observational Study of Disease Progression in Chronic Hepatitis C

Sponsor

Beijing YouAn Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02011932

Collaborator

(none)

133

Enrollment

240

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis C, Chronic Disease Progression Liver Cirrhosis

Study Design

Study Type:

Observational

Actual Enrollment :

133 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Anticipated Study Completion Date :

Jul 1, 2030

Arms and Interventions

Arm	Intervention/Treatment
Healthy volunteers
Chronic hepatitis C

Outcome Measures

Primary Outcome Measures

Fibrosis progression rate [20 years]
The incidence of cirrhosis [20 years]
Risk factors for the occurrence of cirrhosis [20 years]

Secondary Outcome Measures

The incidence of hepatocellular carcinoma [20 years]
Number of participants with chronic hepatitis C-related complications [20 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.