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NCT00555321 · ClinicalTrials.gov registry record · Phase 2

Belatacept in Liver Transplant Recipients

A Phase 2 study, sponsored by Bristol-Myers Squibb.

Terminated
Registry status
Phase 2
Development phase
260
Enrollment target

NCT00555321: Clinical Trial Phase 2 study, sponsored by Bristol-Myers Squibb.

NCT00555321 is a Phase 2 study that was terminated before completion, run by Bristol-Myers Squibb. The registered enrollment target is 260 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (95% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00555321, a Phase 2 study, was terminated before completion, sponsored by Bristol-Myers Squibb.

TERMINATED
Registry status
Phase 2
Development phase
260 participants
Enrollment target

Study Summary

The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

Primary Outcome

Any AR that was clinically suspected and biopsy proven (by central pathologist) was included in this triple composite end point. All biopsies for suspected AR were assessed by a blinded central histopathologist using Banff grading schema. Graft loss was defined as impairment of liver function to such a degree that the participant died or underwent re-transplantation. For 95% (confidence interval) CI within each group, normal approximation is used if N\>=5, otherwise exact method is used.

Interventions

  • DRUG Tacrolimus
  • DRUG Mycophenolate Mofetil (MMF)
  • DRUG Basiliximab
  • DRUG Belatacept More Intensive (MI)
  • DRUG Belatacept Less Intensive (LI)

Trial Details

FieldValue
Enrollment Target 260 participants
Start Date 2008-01
Est. Completion 2011-06
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

Why NCT00555321 stopped before completion

NCT00555321 is an interventional study that assigns participants to a tested intervention. The registered 260 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 (95% higher).

The record links to 0 conditions, and to 5 interventions - of which Tacrolimus is the first listed.

NCT00555321 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00555321 about?

NCT00555321 is a clinical study titled "Belatacept in Liver Transplant Recipients". The purpose of this clinical research study is to evaluate the effects of belatacept, relative to tacrolimus, on the incidence of rejection, graft loss and death in subjects receiving a liver transplant

What is the current status of trial NCT00555321?

This trial is currently terminated. It is a Phase 2 study. The enrollment target is 260 participants. The study started on 2008-01. Estimated completion is 2011-06.

What interventions are being tested in trial NCT00555321?

The interventions under investigation include: Tacrolimus (DRUG), Mycophenolate Mofetil (MMF) (DRUG), Basiliximab (DRUG), Belatacept More Intensive (MI) (DRUG), Belatacept Less Intensive (LI) (DRUG).

Who is sponsoring clinical trial NCT00555321?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00555321's enrollment target sits among peer trials

260 210th of 2000 higher than 1,789 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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Source: ClinicalTrials.gov NCT00555321, the US trial registry maintained by the National Library of Medicine. NCT00555321 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.