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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: Completed Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
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, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (107% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
This is a composite endpoint comprising clinical complications related to immunosuppression and is defined as the occurrence of any of the following: death or graft loss, grade 4 secondary malignancy (graded by Common Terminology Criteria for Adverse Events \[CTCAE\] version 3.0), grade 4 opportunistic infection (graded by CTCAE version 3.0), stage 3 or higher fibrosis, or decrease in renal function. Decrease in renal function is defined as: a) the estimated glomerular filtration rate (eGFR) usi
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 |
What the finished NCT00135694 record still lists
NCT00135694 is an interventional study that assigns participants to a tested intervention. The registered 275 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (107% higher).
The record links to 0 conditions, and to 4 interventions - of which corticosteroids is the first listed.
NCT00135694 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00135694's enrollment target sits among peer trials
275 203rd of 2000 higher than 1,798 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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