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NCT01769443 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of Desensitization Therapy in Sensitized Participants Awaiting Heart Transplantation
A Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01769443: Clinical Trial Phase 2 study, sponsored by National Institute of Allergy and Infectious Diseases (NIAID).
NCT01769443 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 2 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01769443, 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
- 2 participants
- Enrollment target
Study Summary
The primary objective is to evaluate the efficacy of desensitization therapy, which includes VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart transplantation.
Primary Outcome
* Death, * Removal from the transplant waiting list for any reason except improvement of cardiac function, * Initiation of any mechanical circulatory support device, * Severe infection requiring intravenous antibiotics, * Cerebral vascular accident, * Acute renal failure requiring dialysis.
Interventions
- DRUG bortezomib
- PROCEDURE plasmapheresis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
Why NCT01769443 stopped before completion
NCT01769443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which bortezomib is the first listed.
NCT01769443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01769443 about?
NCT01769443 is a clinical study titled "Safety and Efficacy of Desensitization Therapy in Sensitized Participants Awaiting Heart Transplantation". The primary objective is to evaluate the efficacy of desensitization therapy, which includes VELCADE® (bortezomib) and plasmapheresis, on select sensitized patients awaiting heart transplantation.
What is the current status of trial NCT01769443?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2013-06. Estimated completion is 2014-07.
What interventions are being tested in trial NCT01769443?
The interventions under investigation include: bortezomib (DRUG), plasmapheresis (PROCEDURE).
Who is sponsoring clinical trial NCT01769443?
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 NCT01769443's enrollment target sits among peer trials
2 2001st of 2000 the lowest 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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