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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 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.

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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.

Interventions

  • BIOLOGICAL Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper)
  • DRUG Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper)

Trial Details

FieldValue
Enrollment Target 362 participants
Start Date 2011-09
Est. Completion 2015-10
Phase Phase 2

What the Registry Record Tells You About NCT01278745

The ClinicalTrials.gov registry entry for NCT01278745 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 362 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 2 interventions - of which Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper) is the first listed.

NCT01278745 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

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