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| Sponsors and Collaborators: |
Hospital Clinic of Barcelona Fresenius AG Astellas Pharma Inc |
|---|---|
| Information provided by: | Hospital Clinic of Barcelona |
| ClinicalTrials.gov Identifier: | NCT00436722 |
Purpose
This is a randomized, controlled trial in liver transplantation in which conventional immunosuppressive treatment will be compared with a therapeutic strategy consisting in pre-transplant antibody-mediated T cell depletion followed by reduced calcineurin inhibitor usage. The working hypothesis is that antibody induction followed by calcineurin inhibitor minimization may promote development of tolerogenic mechanisms allowing the eventual withdrawal of all immunosuppressive therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Liver Diseases |
Drug: ATG (Fresenius Biotech) |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Study of ATEGE-Fresenius Induction in Liver Transplantation Followed by Tacrolimus Weaning. |
| Estimated Enrollment: | 72 |
| Study Start Date: | June 2006 |
| Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Spain | |
| Hospital Clinic Barcelona, University of Barcelona | |
| Barcelona, Spain, 08036 | |
| Principal Investigator: | Alberto Sanchez-Fueyo | Hospital Clinic Barcelona, Barcelona, Spain |
More Information
| Responsible Party: | Hospital Clinic of Barcelona ( Miguel navasa ) |
| Study ID Numbers: | EudraCT 2005-005635-10 |
| Study First Received: | February 16, 2007 |
| Last Updated: | May 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00436722 History of Changes |
| Health Authority: | Spain: Spanish Agency of Medicines |
|
Liver Transplantation Tolerance Induction |
Tacrolimus Liver transplantation Adult |
|
Antilymphocyte Serum Antibodies Liver Diseases Digestive System Diseases |
Immunologic Factors Tacrolimus Immunosuppressive Agents Immunoglobulins |
|
Antilymphocyte Serum Liver Diseases Digestive System Diseases Immunologic Factors |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |