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NCT00368225 · ClinicalTrials.gov registry record
Transplant-Related Accelerated Progression of Hepatitis C
A clinical trial, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- 100
- Enrollment target
NCT00368225: Completed study, sponsored by National Institutes of Health Clinical Center (CC).
NCT00368225 is a clinical trial that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 100 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00368225 has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- 100 participants
- Enrollment target
Study Summary
This study will explore why severe scarring of the liver (cirrhosis) develops so rapidly in hepatitis C-infected patients who have had a liver transplant and possibly in kidney transplant patients as well. The hepatitis C virus (HCV) can cause cirrhosis in about 20 percent of infected persons. Generally, it takes 20 years or more for cirrhosis to develop. After liver transplantation, however, patients may develop cirrhosis in as little as 5 years. Cirrhosis does not develop as rapidly in kidney transplant patients, but it may develop faster than in people who do not undergo transplantation. The study will look at the possible role of immune-suppressing medications given to liver and kidney transplant patients in increasing the severity of hepatitis C infection and in speeding the cirrhotic process. Patients 18 years of age and older with chronic HCV infection who require a liver transplant for end-stage liver disease or a kidney transplant for kidney failure may be eligible for this study. Liver transplant patients are recruited from the Inova Fairfax Liver Transplant Center in Fairfax, Virginia, and from the Georgetown University Medical Center Liver Transplant Institute in Washington, D.C. Kidney transplant patients are recruited from the Transplantation Branch of the National Institute of Diabetes and Digestive and Kidney Diseases. Participants undergo the following procedures: * Regular care: As part of their regular transplant-related treatment, patients have a medical history, physical examinations and blood draws before their transplant and on regularly scheduled visits after the transplant. * Blood draws for research: Special blood tests are done to measure the immune response to HCV. They measure the amount of HCV in the blood, the number of HCV strains present and how they change over time and the HCV antibodies in the blood. * Liver biopsies: This procedure is done at 3 months, 1 year, 3 years and 5 years after the transplant to determine the extent of
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2006-06-22 |
| Est. Completion | 2009-01-22 |
What the finished NCT00368225 record still lists
NCT00368225 is an observational study that tracks outcomes without assigning an intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00368225 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00368225 about?
NCT00368225 is a clinical study titled "Transplant-Related Accelerated Progression of Hepatitis C". This study will explore why severe scarring of the liver (cirrhosis) develops so rapidly in hepatitis C-infected patients who have had a liver transplant and possibly in kidney transplant patients as well. The hepatitis C virus (HCV) can cause cirrhosis in about 20 percent of infected persons. Gener...
What is the current status of trial NCT00368225?
This trial is currently completed. The enrollment target is 100 participants. The study started on 2006-06-22. Estimated completion is 2009-01-22.
Who is sponsoring clinical trial NCT00368225?
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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