Back to resultsHistory of Hepatitis C in Volunteer Blood Donors
Primary Purpose
Hepatitis C
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Hepatitis C focused on measuring Aminotransferases, Anti-HCV, Blood Donors, HCV RNA, Hepatitis C, Liver Biopsy, Serum Aminotransferases, Transfusion
Eligibility Criteria
Patients with chronic hepatitis C. Age 18 to 70 years, male or female. HCV infection indicated by the presence of anti-HCV (by ELISA and recombinant immunoblot assay [RIBA]). Written informed consent. Women must not be pregnant. Patients must not have significant systemic illnesses other than liver disease, including congestive heart failure, renal failure, uncontrolled diabetes mellitus. Patients must not have antiviral or immunosuppressive therapy within the last 6 months. Patients must not have HIV infection. Patients must not have contraindications to liver biopsy (mainly clotting abnormality (coumadin therapy, platelet count less than 50,000/cubic millimeter, prothrombin time more than 4 seconds beyond control)).
Sites / Locations
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001982
First Posted
January 21, 2000
Last Updated
March 3, 2008
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
1. Study Identification
Unique Protocol Identification Number
NCT00001982
Brief Title
History of Hepatitis C in Volunteer Blood Donors
Official Title
Natural History of Chronic Hepatitis C Among Volunteer Blood Donors
Study Type
Observational
2. Study Status
Record Verification Date
May 1999
Overall Recruitment Status
Completed
Study Start Date
June 1993 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2000 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
4. Oversight
5. Study Description
Brief Summary
Hepatitis C is a disease of the liver caused by the Hepatitis C Virus (HCV). Patients with hepatitis C may feel well and show no signs or symptoms of being ill. However, researchers would like to study the long-term effects of this disease.
Volunteer blood donors diagnosed with chronic hepatitis C viral (HCV) and various levels of liver enzyme activity will be offered a complete medical evaluation and liver biopsy. The tests will enable researchers to provide the patients with an idea of how severe their liver disease is. The virus and patient will be studied in order to understand why patients with hepatitis C develop different levels of liver damage.
Detailed Description
A selected sample of volunteer blood donors with chronic hepatitis C viral (HCV) infection and various levels of serum aminotransferase activity will be offered a complete medical evaluation and liver biopsy to determine the severity of their liver disease. Various virological and host factors will be studied in an attempt to determine why patients with HCV infection develop differing degrees of liver disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C
Keywords
Aminotransferases, Anti-HCV, Blood Donors, HCV RNA, Hepatitis C, Liver Biopsy, Serum Aminotransferases, Transfusion
7. Study Design
Enrollment
60 (false)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Patients with chronic hepatitis C.
Age 18 to 70 years, male or female.
HCV infection indicated by the presence of anti-HCV (by ELISA and recombinant immunoblot assay [RIBA]).
Written informed consent.
Women must not be pregnant.
Patients must not have significant systemic illnesses other than liver disease, including congestive heart failure, renal failure, uncontrolled diabetes mellitus.
Patients must not have antiviral or immunosuppressive therapy within the last 6 months.
Patients must not have HIV infection.
Patients must not have contraindications to liver biopsy (mainly clotting abnormality (coumadin therapy, platelet count less than 50,000/cubic millimeter, prothrombin time more than 4 seconds beyond control)).
Facility Information:
Facility Name
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
2496467
Citation
Kuo G, Choo QL, Alter HJ, Gitnick GL, Redeker AG, Purcell RH, Miyamura T, Dienstag JL, Alter MJ, Stevens CE, et al. An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis. Science. 1989 Apr 21;244(4902):362-4. doi: 10.1126/science.2496467.
Results Reference
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PubMed Identifier
1280771
Citation
Alter MJ, Margolis HS, Krawczynski K, Judson FN, Mares A, Alexander WJ, Hu PY, Miller JK, Gerber MA, Sampliner RE, et al. The natural history of community-acquired hepatitis C in the United States. The Sentinel Counties Chronic non-A, non-B Hepatitis Study Team. N Engl J Med. 1992 Dec 31;327(27):1899-905. doi: 10.1056/NEJM199212313272702.
Results Reference
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History of Hepatitis C in Volunteer Blood Donors
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