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NCT00004850 · ClinicalTrials.gov registry record
Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 805
- Enrollment target
NCT00004850: Completed study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00004850 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 805 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00004850 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 805 participants
- Enrollment target
Study Summary
This study will evaluate hepatitis C virus (HCV) infection in blood donors who test positive for antibodies to this virus. Most HCV-infected people do not become ill and are not aware that they have hepatitis or have had it in the past. Some infected people recover completely, whereas others remain chronically infected. The study will try to define infectivity of anti-HCV positive individuals, routes of transmission of the virus, and the number of HCV-infected persons who have evidence of liver disease. Blood donors at the NIH Clinical Center or the Central Maryland Chapter of the American Red Cross who test positive for HCV may be eligible for this study. Participants will have a physical examination and history, including questions about socioeconomic status and current sexual practices. They will have 100 milliliters (ml) (6 tablespoons) of blood drawn at the first visit and 50 ml (3 tablespoons) drawn 3, 6, 9 and 12 months after the initial visit. Some participants may undergo plasmapheresis, a procedure for collecting additional plasma (the liquid portion of the blood). For this procedure, whole blood is collected through a needle placed in an arm vein. The blood circulates through a machine that separates it into its components. The plasma is then removed, and the red and white cells and platelets are returned to the body, either through the same needle used to draw the blood or through a second needle placed in the other arm. In some individuals, other body fluids (saliva, urine or semen) may also be collected. Participants may be asked to bring their household contacts and sexual partners to NIH for interview and blood testing for evidence of HCV infection and liver disease. Although this is not required for participation in the study, it would provide additional valuable information. Participants found to have chronic viral infection will be seen more often and will provide additional blood samples for routine medical care. Further medical evaluation may
Primary Outcome
To determine clinical outcomes and long term sequelae of those infected with chronic HCV, HBV and coninfection HBV/HCV.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 805 participants |
| Start Date | 1991-03-15 |
What the finished NCT00004850 record still lists
NCT00004850 is an observational study that tracks outcomes without assigning an intervention. The registered 805 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00004850 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00004850 about?
NCT00004850 is a clinical study titled "Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection". This study will evaluate hepatitis C virus (HCV) infection in blood donors who test positive for antibodies to this virus. Most HCV-infected people do not become ill and are not aware that they have hepatitis or have had it in the past. Some infected people recover completely, whereas others remain ...
What is the current status of trial NCT00004850?
This trial is currently completed. The enrollment target is 805 participants. The study started on 1991-03-15.
Who is sponsoring clinical trial NCT00004850?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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