History of Hepatitis C in Volunteer Blood Donors

Hepatitis C Clinical Trial

Official title:

Natural History of Chronic Hepatitis C Among Volunteer Blood Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001982
• Other study ID #: 930159
• Secondary ID: 93-DK-0159
• Status: Completed
• Phase: N/A
• First received: January 21, 2000
• Last updated: March 3, 2008
• Start date: June 1993
• Est. completion date: April 2000

Study information

• Verified date: May 1999
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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)).

Study Design

N/A

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C

Locations

Country	Name	City	State
United States	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation