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Belatacept in Liver Transplant Recipients

NCT00555321 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2012-10-18

Study results available
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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

Conditions

  • Immunosuppression in Solid Organ Transplant

Interventions

DRUG

Tacrolimus

Capsules, Oral, dosed to achieve 12 hour trough level of 6-12 ng/mL, twice daily, 52 weeks (Short Term \[ST\]), in accordance with local practice and the package insert, 4 years (Long-Term Extension \[LTE\])

DRUG

Basiliximab

Intravenous (IV), 20 mg, Day1 and Day 5

DRUG

Belatacept More Intensive (MI)

Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension \[LTE\])

DRUG

Belatacept Less Intensive (LI)

Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term \[ST\]), 5 mg/kg, every 4 weeks, 4 years (Long-Term Extension(LTE)

DRUG

Mycophenolate Mofetil (MMF)

Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term \[ST\]), ≤ 1 g/day, 4 years (Long-term extension \[LTE\])

Sponsors & Collaborators

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2010-03-31
Completion
2011-06-30

Countries

  • United States
  • Argentina
  • Austria
  • Brazil
  • Canada
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555321 on ClinicalTrials.gov