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NCT01556347 · ClinicalTrials.gov registry record · Phase 2
Multi-Drug Desensitization Protocol for Heart Transplant Candidates
A Phase 2 study, sponsored by Providence Health & Services.
- Terminated
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
NCT01556347 is a Phase 2 study that was terminated before completion, run by Providence Health & Services. The registered enrollment target is 2 participants.
The verdict
NCT01556347, a Phase 2 study, was terminated before completion, sponsored by Providence Health & Services.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
Study Summary
Background: Patients may develop antibodies (human leukocyte antigen \[HLA\] alloantibodies) to other human tissues via pregnancy, transfusions or previous transplantation, which limits the ability to find an acceptable donor heart for transplantation. Such patients are at high risk for antibody mediated rejection, graft failure, and acute rejection (i.e. death). For successful transplantation, patients must receive organs from donors who lack the HLA antigens that correspond to their alloantibody specificities. No successful desensitization strategy currently exists. Purpose: To determine if desensitization by deletion of immunologic memory with a multi-drug approach including anti-T and B cell therapies and anti-plasma cell therapy can effectively eliminate or significantly reduce alloantibody levels and permit highly sensitized patients to obtain a heart transplant. This therapy is anticipated to remove immunologic memory and will require re-immunization.
Interventions
- DRUG Bortezomib, Thymoglobulin, Rituximab, Gamimune N, (IVIG), Plasmapheresis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2012-07 |
| Est. Completion | 2016-05 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01556347
The ClinicalTrials.gov registry entry for NCT01556347 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Providence Health & Services, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Bortezomib, Thymoglobulin, Rituximab, Gamimune N, (IVIG), Plasmapheresis is the first listed.
NCT01556347 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01556347 about?
NCT01556347 is a clinical study titled "Multi-Drug Desensitization Protocol for Heart Transplant Candidates". Background: Patients may develop antibodies (human leukocyte antigen \[HLA\] alloantibodies) to other human tissues via pregnancy, transfusions or previous transplantation, which limits the ability to find an acceptable donor heart for transplantation. Such patients are at high risk for antibody med...
What is the current status of trial NCT01556347?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2012-07. Estimated completion is 2016-05.
What interventions are being tested in trial NCT01556347?
The interventions under investigation include: Bortezomib, Thymoglobulin, Rituximab, Gamimune N, (IVIG), Plasmapheresis (DRUG).
Who is sponsoring clinical trial NCT01556347?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
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