Prospective Observational Study of Disease Progression in Chronic Hepatitis C

NCT ID: NCT02011932

Last Updated: 2013-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

133 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-07-31

Study Completion Date

2030-07-31

Brief Summary

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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

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Conditions

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Hepatitis C, Chronic Disease Progression Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy volunteers

No interventions assigned to this group

Chronic hepatitis C

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing YouAn Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhongping Duan

Associate Dean,Professor,Chief Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhongping Duan, Ph.D.,M.D.

Role: PRINCIPAL_INVESTIGATOR

Beijing YouAn Hospital

References

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Seeff LB. Natural history of chronic hepatitis C. Hepatology. 2002 Nov;36(5 Suppl 1):S35-46. doi: 10.1053/jhep.2002.36806.

Reference Type BACKGROUND
PMID: 12407575 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9121257 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12512034 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10644270 (View on PubMed)

Other Identifiers

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BJYAH-2011-045

Identifier Type: -

Identifier Source: org_study_id