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History of Hepatitis C in Volunteer Blood Donors

This study has been completed.
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: January 21, 2000
Last updated: March 3, 2008
Last verified: May 1999

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.

Hepatitis C

Study Type: Observational
Official Title: Natural History of Chronic Hepatitis C Among Volunteer Blood Donors

Resource links provided by NLM:

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 60
Study Start Date: June 1993
Estimated Study Completion Date: April 2000
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)).

  Contacts and Locations
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Please refer to this study by its identifier: NCT00001982

United States, Maryland
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Publications: Identifier: NCT00001982     History of Changes
Other Study ID Numbers: 930159
Study First Received: January 21, 2000
Last Updated: March 3, 2008

Keywords provided by National Institutes of Health Clinical Center (CC):
Blood Donors
Hepatitis C
Liver Biopsy
Serum Aminotransferases

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections processed this record on May 25, 2017