Liver Transplantation Clinical Trial
— TILTOfficial title:
A Phase II Multicenter Trial to Assess the Safety and Efficacy of Campath-1H and Tacrolimus Followed By Immunosuppression Withdrawal in Liver Transplantation (ITN024ST)
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.
Status | Completed |
Enrollment | 27 |
Est. completion date | March 2011 |
Est. primary completion date | March 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Canada | University of Alberta | Edmonton | Alberta |
United States | University of Michigan | Ann Arbor | Michigan |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Baylor University | Dallas | Texas |
United States | University of Colorado | Denver | Colorado |
United States | University of Wisconsin | Madison | Wisconsin |
United States | University of Miami School of Medicine | Miami | Florida |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
National Institute of Allergy and Infectious Diseases (NIAID) | Immune Tolerance Network (ITN) |
United States, Canada,
First MR. Tacrolimus based immunosuppression. J Nephrol. 2004 Nov-Dec;17 Suppl 8:S25-31. Review. — View Citation
Tryphonopoulos P, Madariaga JR, Kato T, Nishida S, Levi DM, Moon J, Selvaggi G, De Faria W, Regev A, Bejarano P, Khaled A, Safdar K, Esquenazi V, Weppler D, Yoshida H, Ruiz P, Miller J, Tzakis AG. The impact of Campath 1H induction in adult liver allotransplantation. Transplant Proc. 2005 Mar;37(2):1203-4. — View Citation
Tzakis AG, Tryphonopoulos P, Kato T, Nishida S, Levi DM, Madariaga JR, Gaynor JJ, De Faria W, Regev A, Esquenazi V, Weppler D, Ruiz P, Miller J. Preliminary experience with alemtuzumab (Campath-1H) and low-dose tacrolimus immunosuppression in adult liver transplantation. Transplantation. 2004 Apr 27;77(8):1209-14. Erratum in: Transplantation. 2004 Aug 15;78(3):489. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of Participants Who Have Graft Loss or Death | Proportion of participants who had liver graft loss or who died within 1 year of undergoing transplantation. Note: Participants who discontinued treatment or terminated the study prior to 1 year post transplantation are considered treatment failures and are included in this measure. | Within 1 year of post-transplantation | Yes |
Secondary | Proportion of Participants Who Had Graft Loss or Death | Proportion of participants who had liver graft loss or who died or terminated from the study within 2 years of initiating immunosuppression withdrawal | Within 2 years after initiation of immunosuppression withdrawal | Yes |
Secondary | Number of Events: Immunosuppression-related Complications | Certain events are associated with immunosuppression. This measure looks at post-transplant infection, post-transplant malignancies, post-transplant diabetes, and post-transplant renal failure. Immunosuppression withdrawal is intended to reduce these type of events. However, reduction in immunosuppression can lead to complications in liver and renal function, as measured by acute rejection, chronic rejection, and post-transplant renal failure. Lower numbers for any of these events indicates greater success with transplantation and immunosuppression withdrawal (where applicable) | From transplantation until study completion or participant termination (participants followed up to 60 months) | Yes |
Secondary | Proportion of Participants Successfully Withdrawn From Immunosuppressants | This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks. | From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant) | Yes |
Secondary | Proportion of Participants Successfully Withdrawn and Remain Off Immunosuppressants | This measure of tolerance induction includes the proportion of participants who qualify for immunosuppression withdrawal as determined by a review of individual clinical results by a protocol withdrawal committee, were successfully withdrawn from immunosuppressants, and remained off immunosuppressants at the time the trial ended. Successful withdrawal definition: participants who remain off immunosuppression for at least 8 weeks and do not restart immunosuppressant drugs after successful withdrawal. | From 1 year post- transplantation until study completion or participant termination (participants followed up to 48 months post-transplant) | No |
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