Prospective Observational Study of Disease Progression in Chronic Hepatitis C

Active, not recruiting

• Conditions: Hepatitis C, Chronic; Disease Progression; Liver Cirrhosis

• Registration Number: NCT02011932
• Lead Sponsor: Beijing YouAn Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07
• Primary Completion: 2011-06
• Status Verified: 2013-12
• Study First Submitted: 2013-12-06
• Study First Submitted QC: 2013-12-10
• Last Update Submitted: 2013-12-13
• Study First Posted: 2013-12-16
• Last Update Posted: 2013-12-17
• Study Completion: 2030-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 133

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Fibrosis progression rate	20 years
The incidence of cirrhosis	20 years
Risk factors for the occurrence of cirrhosis	20 years

Secondary Outcome Measures

Name	Time	Method
Number of participants with chronic hepatitis C-related complications	20 years
The incidence of hepatocellular carcinoma	20 years