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Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection Clinical research trials and Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection. Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection clinical trial. Human subjects often get the best healthcare possible for their Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection  Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection
Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection
For Condition: Hepatitis C
Status: Recruiting
Sponsor(s): Warren G Magnuson Clinical Center (CC) ,
Synopsis: 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 include X-rays or liver scans and referral to a specialist for additional tests or therapy. Ten people in this study will be recruited to participate in a secondary investigation to analyze changes in the level of HCV and the immune response to it, and to relate these changes to the degree of liver damage. In addition to blood collected for the primary study, participants in this investigation will have an additional 50 ml (3 tablespoons) of blood drawn from an arm vein every week for 10 weeks to measure levels of virus, ALT (a liver enzyme), and immune response.
Details: At initiation of this study in 1991, approximately 0.6% of U.S. blood donors were identified as having antibody to the hepatitis C virus (anti-HCV). This represented 72,000 of the estimated 12 million annual U.S. blood donations. By investigating a cohort of anti-HCV positive donors, this study aims to determine: 1) the specificity of the HCV antibody assay; 2) the primary routes of HCV transmission in an asymptomatic donor population; 3) the relationship between anti-HCV and evidence of acute or chronic liver disease; 4) the infectivity of anti-HCV positive individuals as judged by measurement of HCV RNA and by investigation of their sexual partners and prior blood recipients; 5) the chronic consequences of HCV infection. The study does not directly provide treatment for HCV infection. Enrollment is limited to persons identified as anti-HCV positive at the time of blood donation and persons from any source found to have clinical or molecular evidence of acute hepatitis C virus infection.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Blood donors will be enrolled from among participants in the blood programs of the National Institutes of Health/Clinical Center/Department of Transfusion Medicine (NIH/CC/DTM) and the American Red Cross/Central Maryland Chapter/The Greater Chesapeake and Potomac Regional Blood Services (ARC). Enrollment will be restricted to those who test positive in the anti-HCV screening assay. To fulfill criteria for study entry, the donor must: a) be anti-HCV+ at the time of donation. b) be 18 years of age or older. c) be able/willing to travel to NIH for blood sampling 4 times in the first year of study and semi-annually thereafter and willing to have an annual history and physical examination. d) provide informed consent. EXCLUSION CRITERIA: Donors who do not consent or who do not meet eligibility criteria will be excluded from the study with appropriate explanation.
Total Enrollment: 1000
Location and Contact Information:
Warren G. Magnuson Clinical Center (CC) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 910117; 91-CC-0117
Study Start Date: April 25, 1991
Record last reviewed: April 22, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004850
Other Hepatitis C Studies:
1. Comparing Single Photon Emission Computed Tomography (SPECT) and Liver Biopsy to Evaluate the Liver in Patients with HIV and Hepatitis C Virus
2. The Safety and Effectiveness of a Two-Drug Combination in the Treatment of Patients with Hepatitis C Plus Advanced HIV Infections
3. Racial Differences in Hepatitis C Virus (HCV)/Host Interactions
4. Herbal Treatment of Hepatitis C in Methadone Maintained Patients
5. Generation of Anti-HCV Antibodies From Bone Marrow: Defining the Repertoire of Immune Response to HCV Quasispecies
Related Studies:
Other Hepatitis C Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Epidemiology, Infectivity and Natural History of Hepatitis C Virus Infection
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