Liver Cirrhosis Clinical Trial
Official title:
Observational Study of Disease Progression and Risk Factors in Chronic Hepatitis C Caused by Plasma Donation
Verified date | December 2013 |
Source | Beijing YouAn Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | China: Institutional Review Board |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 133 |
Est. completion date | July 2030 |
Est. primary completion date | June 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Beijing YouAn Hospital |
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. — View Citation
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. — View Citation
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. — View Citation
Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fibrosis progression rate | 20 years | No | |
Primary | The incidence of cirrhosis | 20 years | No | |
Primary | Risk factors for the occurrence of cirrhosis | 20 years | No | |
Secondary | The incidence of hepatocellular carcinoma | 20 years | No | |
Secondary | Number of participants with chronic hepatitis C-related complications | 20 years | No |
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