History of Hepatitis C in Volunteer Blood Donors

NCT00001982 | Completed

• 2 other identifiers: 93015993-DK-0159
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatitis C

Keywords

Aminotransferases; Anti-HCV; Blood Donors; HCV RNA; Hepatitis C; Liver Biopsy; Serum Aminotransferases; Transfusion

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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)).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): lead

Study Sites (1)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

• 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.

  PMID: 2496467 BACKGROUND

• 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.

  PMID: 1280771 BACKGROUND

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: January 21, 2000
• First Posted: December 10, 2002
• Study Start: June 1, 1993
• Study Completion: April 1, 2000
• Last Updated: March 4, 2008

Record last verified: 1999-05

Locations

US (1)