At a glance
ClinicalIndex Comparison Record- ✓Diagnosis of nonimmune, nonviral, end-stage liver disease
- ✓Need liver transplant
- ✕Previous transplant
- ✕Multiorgan transplant or living donor transplant
- ✕Donor liver from donor positive for hepatitis B core antibody or hepatitis C virus
- ✕Donor liver from a non-heart-beating donor
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Multicenter Trial to Assess the Safety and Efficacy of Campath-1H and Tacrolimus Followed By Immunosuppression Withdrawal in Liver Transplantation (ITN024ST)
In Brief
A Phase 2 clinical trial evaluating Alemtuzumab, Cyclosporine, and 4 other interventions for Liver Disease and Liver Transplantation. Completed, enrolled 27 participants across 9 sites in 2 countries.
Detailed Summary
Alemtuzumab is a man-made antibody used to treat certain blood disorders. Tacrolimus is a drug used to decrease immune system activity in people who have received organ transplants so that the new organ will not be rejected. This study will determine whether treatment with alemtuzumab and tacrolimus is effective in preventing organ rejection and maintaining the recipient's health after liver transplantation in patients with end-stage liver disease, and whether gradual tapering of tacrolimus treatment is safe for these patients.
Study Details
Timeline
Interventions
T-cell depleting monoclonal antibody; two doses by intravenous infusion on Days 0 and 4
Oral immunosuppressant
Oral immunosuppressant
Oral immunosuppressant
Occurs at study entry
Beginning no earlier than Year 1