CLINICAL TRIALS PROFILE FOR HEPATITIS B IMMUNE GLOBULIN INTRAVENOUS (HUMAN)
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All Clinical Trials for hepatitis b immune globulin intravenous (human)
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00031291 ↗ | Plasmapheresis of Anthrax-Vaccinated Subjects for Production of Anthrax Immune Globulin | Completed | National Institutes of Health Clinical Center (CC) | 2002-02-01 | This protocol is a joint project of the National Institutes of Health, the Centers for Disease Control and the United States Army Medical Research Institute for Infectious Diseases. It is designed to collect plasma from healthy employees of the Department of Defense who have been vaccinated against anthrax. The collected plasma will be pooled to make an anthrax-fighting antibody solution called anthrax immune globulin intravenous (AIGIV). This solution will be used for: - Animal experiments to test its effectiveness in preventing the development of anthrax after inhalation exposure; - Treating people severely ill with anthrax who are not improving with standard antibiotic therapy; and - Treating people exposed to spores of the bacteria that cause anthrax to try to prevent development of the disease. Healthy volunteers between 18 and 65 years of age who have received at least four doses of the anthrax vaccine and who meet the criteria for blood donors may be eligible to participate in this study. Volunteers will be recruited from Department of Defense civilian and military employees. Candidates will be screened with an interview and blood tests. Participants will undergo the following procedures: - Have a health history screen for donating plasma - Measurement of heart rate, blood pressure and temperature - Fingerstick to check hemoglobin level - Blood tests for HIV, hepatitis B and C, syphilis and other infectious diseases - Blood test for anthrax antibody levels - Plasmapheresis to collect blood plasma (the liquid part of the blood) In plasmapheresis, whole blood is drawn through a needle placed in an arm vein. The blood flows into a cell separator machine, where it is spun to separate the plasma from the blood cells. The plasma is collected in a plastic bag in the machine, while the rest of the blood is returned to the donor through the needle in the arm. During the procedure, the donor is given a blood thinner called citrate to prevent the blood from clotting while it is in the cell separator machine. The procedure lasts from 60 to 90 minutes. Only a small fraction of the body's total plasma is removed, and it is quickly replaced by the body with no long-term health effects. Participants may be requested to donate plasma as often as every 3 to 4 days or as infrequently as once a month for a maximum of six donations. | |
| NCT00059267 ↗ | Prevention of Recurrent Hepatitis B After Liver Transplantation | Completed | University of Michigan | 2001-03-01 | Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation. | |
| NCT00059267 ↗ | Prevention of Recurrent Hepatitis B After Liver Transplantation | Completed | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 2001-03-01 | Hepatitis B accounts for approximately 5000 deaths per year in the United States. Liver transplantation offers the only hope for patients who develop end-stage liver disease. Early results of liver transplantation for hepatitis B were poor with recurrence rate of 80% and 1-year survival of only 50%. Recent studies found that preventive therapy using hepatitis B immune globulin (HBIG) or antiviral medications such as lamivudine can reduce the recurrence rate to roughly 30% with accompanying improvement in survival. However, HBIG when given as intravenous infusion in high doses is very expensive, while long-term use of lamivudine is associated with drug resistance. Some studies found that preventive therapy using both HBIG and lamivudine may decrease recurrence rate to less than 10% but the dose and duration of HBIG needed when used in combination with lamivudine is not clear. Adefovir, a new antiviral medication, is effective against lamivudine resistant hepatitis B but its role in liver transplantation is uncertain because of the risk of kidney damage. Many studies showed that the risk of recurrent hepatitis B is related to the viral load before transplant. Thus, it may be possible to tailor the preventive therapy according to the risk. The aim of this study is to establish the most cost-effective preventive therapy for recurrent hepatitis B after liver transplantation. | |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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| Sponsor Name for hepatitis b immune globulin intravenous (human) | |
| Sponsor | Trials |
| University of Liverpool | 1 |
| Third Affiliated Hospital, Sun Yat-Sen University | 1 |
| Assistance Publique - Hôpitaux de Paris | 1 |
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