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NCT02011932 Clinical Trial

Prospective Observational Study of Disease Progression in Chronic Hepatitis C

Liver Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02011932
Other study ID # BJYAH-2011-045
Secondary ID
Status Active, not recruiting
Phase N/A
First received December 6, 2013
Last updated December 13, 2013
Start date July 2010
Est. completion date July 2030

Study information
Verified date December 2013
Source Beijing YouAn Hospital
Contact n/a
Is FDA regulated No
Health authority China: Institutional Review Board
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Beijing YouAn Hospital

References & Publications (4)

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

Outcome
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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