Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00105235
Status:
COMPLETED
Last Update Posted:
2012-12-27
First Post:
2005-03-10
Brief Title:
Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TILT
Brief 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 recipients health after liver transplantation in patients with end-stage liver disease and whether gradual tapering of tacrolimus treatment is safe for these patients
Detailed Description:
Organ transplantation is a common procedure in hospitals but organ rejection and serious side effects are potential problems for the patient Alemtuzumab is a monoclonal antibody that binds to and depletes excess T cells in the bone marrow of leukemia patients In this study alemtuzumab will destroy the recipients white blood cells WBCs at the time of transplantation It is hoped that WBCs produced after alemtuzumab administration will recognize the transplanted liver as self and not reject the new liver
Drugs that suppress the immune system such as tacrolimus have contributed to increased success of transplantation However to prevent organ rejection transplant recipients need to take immunosuppressive drugs for the rest of their lives and these drugs make patients more susceptible to infection endangering their health and survival Regimens that are less toxic to or can eventually be withdrawn from transplant recipients are needed This study will evaluate the effects of two in-patient doses of alemtuzumab followed by maintenance antirejection medication given to liver transplant patients post-transplant This study will also determine if post-transplant tacrolimus therapy can be slowly and safely tapered off and withdrawn a year after transplant Participants in this study will be patients with end-stage liver disease who will undergo liver transplantation at the start of the study
This study will last at least 2 years Patients will undergo liver transplantation at the start of the study on Day 0 Patients will receive in-patient infusions of alemtuzumab on Days 0 and 4 Starting on Day 1 patients will receive oral cyclosporine mycophenolate mofetil andor tacrolimus daily Patients will be hospitalized for at least 1 week after transplantation Because of suppression of patients immune systems by alemtuzumab and these other immunosuppressants they will also receive prophylactic medications for a minimum of 3 months after transplantation to prevent opportunistic infections
There will be at least eight study visits they will occur at Days 4 7 and 14 and at Months 1 3 6 9 and 12 Patients will have liver biopsies at Day 0 and Months 6 and 12 At Month 12 participants will have assessments and blood tests to determine if they meet certain criteria and are eligible to undergo tacrolimus tapering Patients eligible for tapering will undergo a 12-month gradual withdrawal of tacrolimus they will be followed for an additional 2 years with study visits at Months 18 24 30 and 36 Patients ineligible for tacrolimus tapering will continue taking their antirejection medication for the duration of the study they will be followed for an additional year with study visits at Months 18 and 24
Drugs that suppress the immune system such as tacrolimus have contributed to increased success of transplantation However to prevent organ rejection transplant recipients need to take immunosuppressive drugs for the rest of their lives and these drugs make patients more susceptible to infection endangering their health and survival Regimens that are less toxic to or can eventually be withdrawn from transplant recipients are needed This study will evaluate the effects of two in-patient doses of alemtuzumab followed by maintenance antirejection medication given to liver transplant patients post-transplant This study will also determine if post-transplant tacrolimus therapy can be slowly and safely tapered off and withdrawn a year after transplant Participants in this study will be patients with end-stage liver disease who will undergo liver transplantation at the start of the study
This study will last at least 2 years Patients will undergo liver transplantation at the start of the study on Day 0 Patients will receive in-patient infusions of alemtuzumab on Days 0 and 4 Starting on Day 1 patients will receive oral cyclosporine mycophenolate mofetil andor tacrolimus daily Patients will be hospitalized for at least 1 week after transplantation Because of suppression of patients immune systems by alemtuzumab and these other immunosuppressants they will also receive prophylactic medications for a minimum of 3 months after transplantation to prevent opportunistic infections
There will be at least eight study visits they will occur at Days 4 7 and 14 and at Months 1 3 6 9 and 12 Patients will have liver biopsies at Day 0 and Months 6 and 12 At Month 12 participants will have assessments and blood tests to determine if they meet certain criteria and are eligible to undergo tacrolimus tapering Patients eligible for tapering will undergo a 12-month gradual withdrawal of tacrolimus they will be followed for an additional 2 years with study visits at Months 18 24 30 and 36 Patients ineligible for tacrolimus tapering will continue taking their antirejection medication for the duration of the study they will be followed for an additional year with study visits at Months 18 and 24
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None