Liver Diseases Clinical Trial
— ATEGE-LIVEROfficial title:
Study of ATEGE-Fresenius Induction in Liver Transplantation Followed by Tacrolimus Weaning.
Verified date | May 2009 |
Source | Hospital Clinic of Barcelona |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Spanish Agency of Medicines |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 72 |
Est. completion date | |
Est. primary completion date | July 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Age > 18 years - Recipient of a primary liver graft - Absence of any of our exclusion criteria Exclusion Criteria: - Pretransplant renal failure, defined as serum creatinine > 1.5 mg/dL - Severe pretransplant thrombopenia, defined as platelets < 50000/mL - Combined liver-kidney transplantation - Autoimmune hepatitis, primary biliary cirrhosis or primary sclerosing cholangitis as causes of liver transplantation - Chronic hepatic encephalopathy - Living donor liver transplantation - Recipient with human immunodeficiency virus infection - Severe pretransplant leukopenia, defined as < 1500 leukocytes/mL |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic Barcelona, University of Barcelona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona | Astellas Pharma Inc, Fresenius AG |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proportion of patients who can significantly decrease the doses of tacrolimus 1 year after transplantation (as defined by: tacrolimus administered on alternate days, or daily with trough levels below 5 ng/mL. | 1 year | No | |
Secondary | Graft survival | 1 year | Yes | |
Secondary | Patient survival | 1 year | Yes | |
Secondary | Incidence of opportunistic infections | 1 year | Yes | |
Secondary | Incidence of acute/chronic rejection | 1 year | Yes | |
Secondary | Incidence of hypertension, renal failure, diabetes, hyperlipidemia | 1 year | Yes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05255042 -
Tissue Models for Liver Disease
|
||
Completed |
NCT04473482 -
Michigan Alcohol Improvement Network- Alcohol Reduction and Treatment Trial
|
N/A | |
Not yet recruiting |
NCT05120557 -
Point-of-care Ultrasound Screening and Assessment of Chronic Liver Diseases and NASH
|
N/A | |
Completed |
NCT02917408 -
Retrospective Study About Primary Biliary Cholangitis During January 2001 to July 2016 at West China Hospital
|
||
Recruiting |
NCT03773887 -
Comparison of Inflammatory Profiles and Regenerative Potential in Alcoholic Liver Disease
|
N/A | |
Recruiting |
NCT00345930 -
DILIN - Prospective Study
|
||
Completed |
NCT00148031 -
Improving Hepatitis C Treatment in Injection Drug Users
|
Phase 4 | |
Terminated |
NCT00031135 -
Total Parenteral Nutrition-Associated Liver Disease
|
Phase 2 | |
Completed |
NCT00005305 -
Hepatitis Delta Infections in Hemophiliacs
|
N/A | |
Completed |
NCT00005304 -
Delta Hepatitis and Liver Disease in Hemophiliacs
|
||
Completed |
NCT00222664 -
Qidong Hepatitis B Intervention Study
|
Phase 4 | |
Recruiting |
NCT06195917 -
Robotic-assisted Percutaneous Transhepatic Puncture
|
N/A | |
Recruiting |
NCT04551742 -
Social & Contextual Impact on Children Undergoing Liver Transplantation
|
||
Completed |
NCT04782050 -
Non-invasive Ultrasound Diagnosis of Chronic Liver Diseases in Hepatology Consultation
|
N/A | |
Completed |
NCT03614039 -
Effect of Probiotic and Smectite Gel on NAFLD
|
N/A | |
Recruiting |
NCT04518852 -
TACE, Sorafenib and PD-1 Monoclonal Antibody in the Treatment of HCC
|
Phase 2 | |
Recruiting |
NCT05499585 -
Treating Pediatric NAFLD With Nutrition
|
N/A | |
Terminated |
NCT03396705 -
Liver Regeneration
|
||
Completed |
NCT04341012 -
Breath Analysis Based Disease Biomarkers of COVID-19 and Other Diseases
|
||
Recruiting |
NCT05733832 -
A Trial of Post-Discharge Transitional Care for Patients With Chronic Liver Disease
|
N/A |