Belatacept in Liver Transplant Recipients - Full Text View

Sponsored by:	Bristol-Myers Squibb
Information provided by:	Bristol-Myers Squibb
ClinicalTrials.gov Identifier:	NCT00555321

Purpose

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

Condition	Intervention	Phase
Immunosuppression in Solid Organ Transplant	Drug: Basiliximab+Belatacept (MI) + MMF Drug: Belatacept (MI) + MMF Drug: Belatacept (LI) + MMF Drug: Tacrolimus + MMF Drug: Tacrolimus	Phase II

MedlinePlus related topics: Liver Transplantation

Drug Information available for: Tacrolimus Tacrolimus anhydrous Basiliximab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Evaluation of Belatacept as First Line Immunosuppression in De Novo Liver Transplant Recipients

Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:

Incidence of acute rejection, death and graft loss [ Time Frame: by 6 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Renal function [ Time Frame: by 12 months ] [ Designated as safety issue: Yes ]
HCV recurrence [ Time Frame: by 12 months ] [ Designated as safety issue: Yes ]
PK characteristics [ Time Frame: throughout the study ] [ Designated as safety issue: No ]
Overall safety [ Time Frame: throughout the study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	250
Study Start Date:	January 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group 1: Experimental	Drug: Basiliximab+Belatacept (MI) + MMF IV/Capsules, IV/Oral, 10 mg/kg, 5 mg/kg,q 4 weeks, 52 weeks
Group 2: Experimental	Drug: Belatacept (MI) + MMF IV/Capsules, IV/Oral, 10 mg/kg, 5 mg/kg, q 4 weeks, 52 weeks
Group 3: Experimental	Drug: Belatacept (LI) + MMF IV/Capsules, IV/Oral, 10 mg/kg, 5 mg/kg, q 4 weeks, 52 weeks
Group 4 Other	Drug: Tacrolimus + MMF Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks
Group 5: Active Comparator	Drug: Tacrolimus Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

First time recipient of deceased donor liver transplant
Age 18-70
HCV positive recipients

Exclusion Criteria:

Renal disease
HIV
Prior solid organ transplant
Cancer within 5 years

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555321

Contacts

Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:		Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.

Show 51 Study Locations

Sponsors and Collaborators

Bristol-Myers Squibb

Investigators

Study Director:

Bristol-Myers Squibb

More Information

BMS Clinical Trials Disclosure This link exits the ClinicalTrials.gov site

For FDA Safety Alerts and Recalls refer to the following link: http://www.fda.gov/MEDWATCH/safety.htm This link exits the ClinicalTrials.gov site

Responsible Party:	Bristol-Myers Squibb ( Study Director )
Study ID Numbers:	IM103-045
Study First Received:	November 7, 2007
Last Updated:	January 6, 2009
ClinicalTrials.gov Identifier:	NCT00555321
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Basiliximab
Abatacept
Tacrolimus

Additional relevant MeSH terms:

Immunologic Factors
Therapeutic Uses
Physiological Effects of Drugs

Antirheumatic Agents
Immunosuppressive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009