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NCT01278745 · ClinicalTrials.gov registry record · Phase 2
Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 362
- Enrollment target
NCT01278745: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01278745 is a Phase 2 study that was terminated before completion, run by National Institute of Allergy and Infectious Diseases (NIAID). The registered enrollment target is 362 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (172% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01278745, a Phase 2 study, was terminated before completion, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 362 participants
- Enrollment target
Study Summary
All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function. People who develop antibodies after transplant have a higher risk of developing CAV. Infections, high cholesterol, and rejection also increase the risk of developing CAV. People who develop CAV usually have to receive another transplant.
Primary Outcome
Nominal or noticeable change, bad or good, from baseline to 1 year in percent atheroma volume (PAV) which is a measure of the degree of coronary arterial obstruction due to host alloimmune processes measured by intravascular ultrasound (IVUS) in a target coronary artery. Thus a decrease in PAV would be an indicator of less obstruction and a better outcome.
Interventions
- BIOLOGICAL Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper)
- DRUG Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 362 participants |
| Start Date | 2011-09 |
| Est. Completion | 2015-10 |
| Phase | Phase 2 |
Why NCT01278745 stopped before completion
NCT01278745 is an interventional study that assigns participants to a tested intervention. The registered 362 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 (172% higher).
The record links to 0 conditions, and to 2 interventions - of which Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper) is the first listed.
NCT01278745 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01278745 about?
NCT01278745 is a clinical study titled "Prevention of Cardiac Allograft Vasculopathy Using Rituximab (Rituxan) Therapy in Cardiac Transplantation". All people who have a heart transplant are at risk for developing cardiac allograft vasculopathy (CAV). CAV means narrowing of the heart transplant vessels, which is associated with poor heart transplant function. People who develop antibodies after transplant have a higher risk of developing CAV. I...
What is the current status of trial NCT01278745?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 362 participants. The study started on 2011-09. Estimated completion is 2015-10.
What interventions are being tested in trial NCT01278745?
The interventions under investigation include: Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper) (BIOLOGICAL), Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper) (DRUG).
Who is sponsoring clinical trial NCT01278745?
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 NCT01278745's enrollment target sits among peer trials
362 122nd of 2000 higher than 1,878 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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