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NCT00059267 · ClinicalTrials.gov registry record
Prevention of Recurrent Hepatitis B After Liver Transplantation
A clinical trial of Hepatocellular Carcinoma and Cirrhosis, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 317
- Enrollment target
- 1
- Study location
NCT00059267 is a study of Hepatocellular Carcinoma and Cirrhosis that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 317 participants, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (24% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00059267, a study of Hepatocellular Carcinoma and Cirrhosis, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 317 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Conditions Studied
Interventions
- DRUG HBIG, Epivir, Hepsera
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 317 participants |
| Start Date | 2001-03 |
| Est. Completion | 2007-11 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00059267
The ClinicalTrials.gov registry entry for NCT00059267 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 317 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 255-participant average among 145 other Hepatocellular Carcinoma trials with a reported enrollment target (24% higher). The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 4 conditions, with Hepatocellular Carcinoma appearing as the primary indexed condition, and to 1 intervention - of which HBIG, Epivir, Hepsera is the first listed.
NCT00059267 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT00059267 about?
NCT00059267 is a clinical study titled "Prevention of Recurrent Hepatitis B After Liver Transplantation". 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%....
What is the current status of trial NCT00059267?
This trial is currently completed. The enrollment target is 317 participants. The study started on 2001-03. Estimated completion is 2007-11.
What conditions does trial NCT00059267 study?
This clinical trial studies the following conditions: Hepatocellular Carcinoma, Cirrhosis, Hepatitis B, Acute Liver Failure.
What interventions are being tested in trial NCT00059267?
The interventions under investigation include: HBIG, Epivir, Hepsera (DRUG).
Who is sponsoring clinical trial NCT00059267?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00059267 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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