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NCT00135694 · ClinicalTrials.gov registry record · Phase 2
Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Completed
- Registry status
- Phase 2
- Development phase
- 275
- Enrollment target
NCT00135694 is a Phase 2 study that has completed, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 275 participants.
The verdict
NCT00135694, a Phase 2 study, has completed, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 275 participants
- Enrollment target
Study Summary
In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted liver. However, these medications can cause long-term side effects, such as infection, kidney problems, diabetes, and cancer. In patients infected with hepatitis C virus (HCV), these medications may increase the risk of HCV infection in the transplanted liver. The purpose of this study is to determine whether a slow withdrawal of immune system-suppressing medications is safe in two groups of subjects: those who receive a liver transplant due to HCV, and those who receive a liver transplant due to non-immune, non-viral causes of liver failure. The study will also look at whether slow withdrawal will help reduce the long-term side effects of immune system-suppressing medications and decrease the chance for HCV infection of the new liver in transplant patients with HCV.
Interventions
- DRUG corticosteroids
- DRUG calcineurin inhibitor-based immunosuppression
- PROCEDURE liver transplant
- OTHER immunosuppression withdrawal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 275 participants |
| Start Date | 2005-10 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00135694
The ClinicalTrials.gov registry entry for NCT00135694 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 275 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which corticosteroids is the first listed.
NCT00135694 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00135694 about?
NCT00135694 is a clinical study titled "Gradual Withdrawal of Immune System Suppressing Drugs in Patients Receiving a Liver Transplant". In order to prevent organ rejection, patients receiving liver transplants currently require life-long treatment with immune system-suppressing medications to prevent the rejection of the transplanted liver. However, these medications can cause long-term side effects, such as infection, kidney proble...
What is the current status of trial NCT00135694?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 275 participants. The study started on 2005-10. Estimated completion is 2015-09.
What interventions are being tested in trial NCT00135694?
The interventions under investigation include: corticosteroids (DRUG), calcineurin inhibitor-based immunosuppression (DRUG), liver transplant (PROCEDURE), immunosuppression withdrawal (OTHER).
Who is sponsoring clinical trial NCT00135694?
This trial is sponsored by National Institute of Allergy and Infectious Diseases (NIAID), which has 2,006 total clinical trials registered on ClinicalTrials.gov.
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