Phase 2
N=27
Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients
Liver Disease · Liver Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00105235 ↗Enrolled (actual)
27
Serious AEs
100.0%
Results posted
Apr 2012
Primary outcome: Primary: Proportion of Participants Who Have Graft Loss or Death — 0.22 Proportion of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Alemtuzumab (Drug); Cyclosporine (Drug); Mycophenolate mofetil (Drug); Tacrolimus (Drug); Liver transplant (Procedure); Immunosuppression withdrawal (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
- Primary completion
- Mar 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Who Have Graft Loss or Death |
0.22 | — |
| SECONDARY Proportion of Participants Who Had Graft Loss or Death |
— | — |
| SECONDARY Number of Events: Immunosuppression-related Complications |
6; 0; 0; 0; 1; 0 | — |
| SECONDARY Proportion of Participants Successfully Withdrawn From Immunosuppressants |
0.2 | — |
| SECONDARY Proportion of Participants Successfully Withdrawn and Remain Off Immunosuppressants |
0.1 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of nonimmune, nonviral, end-stage liver disease
- Need liver transplant
- Willing to use acceptable means of contraception for the duration of the study
Exclusion Criteria
- Previous transplant
- Multiorgan transplant or living donor transplant
- Donor liver from a donor positive for antibody against hepatitis B core antigen or hepatitis C virus
- Donor liver from a non-heart-beating donor
- Liver failure due to autoimmune disease, such as autoimmune hepatitis, primary sclerosing cholangitis, or primary biliary cirrhosis
- Hepatitis B or C virus infection
- HIV infection
- Stage III or higher hepatocellular cancer based on pre-transplant imaging
- History of cancer. Patients with hepatocellular cancer, adequately treated in situ cervical carcinoma, or adequately treated basal or squamous cell carcinoma of skin are not excluded.
- Active systemic infection at the time of transplantation
- Clinically significant chronic renal, cardiovascular, or cerebrovascular disease
- Any investigational drug within 6 weeks of study entry
- Hypersensitivity to alemtuzumab or tacrolimus
Data sourced from ClinicalTrials.gov (NCT00105235). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.