Clinical Trials

4 studies in Liver Transplant

1. Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients Rochester, MN View Summary
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   Extension Study to Evaluate the Long-term Efficacy and Safety of Everolimus in Liver Transplant Recipients

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The reason for this extension is to evaluate the long-term safety and efficacy of two concentration-controlled everolimus regimen in de novo liver transplant recipients. The most important long-term safety assessments include evaluation of renal function, progression of HCV related allograft fibrosis, and other treatment related effects at Month 36 post-transplantation compared to extension baseline (Months 24 post-transplantation).

   NCT ID:

   NCT01150097

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   Who can I contact for additional information about this study?

   Rochester: Novartis Pharmaceuticals 862-778-8300
                       
   
   
   

2. Endotracheal Cardiac Output Monitor (ECOM) for Patients Undergoing Liver Transplantation Jacksonville, FL View Summary
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   Endotracheal Cardiac Output Monitor (ECOM) for Patients Undergoing Liver Transplantation

   Location:

   Jacksonville, FL

   Trial status:

   Open for Enrollment

   Why is this study being done?

   The purpose of this study is to determine whether the endotracheal cardiac output monitor (ECOM) is accurate and predictive in liver failure patients with hyperdynamic circulatory changes.

   NCT ID:

   NCT01299441

   IRB Number:

   10-007600

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3. Cardiopulmonary Exercise Testing in Cirrhotic Patients: a Pilot Study Rochester, MN View Summary
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   Cardiopulmonary Exercise Testing in Cirrhotic Patients: a Pilot Study

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Subjects: 10 patients ≥40 years of age with cirrhotic end-stage liver disease undergoing liver transplantation evaluation at Mayo Clinic, Rochester, MN. Patients who require multi-organ transplant, or who have non-cirrhotic liver disease (neuroendocrine, amyloidosis, etc.) will be excluded. Each subject will undergo both standard CPET and modified 3 minute step test. Exercise testing. Subjects will perform both tests during one visit to the cardiopulmonary research lab. A 30-60 minute period between tests will given. 5 patients will perform submaximal stress testing first and 5 will perform the full CPET first. CPET: Patients will perform a 6 minute cardiopulmonary exercise test using the recumbent stationary bicycle facilitated by the co-investigators at the St Mary's cardiopulmonary exercise laboratory. Standard 12-lead electrocardiograms will be obtained at rest, each minute during exercise, and for at least five minutes during the recovery phase; blood pressure will be measured using a standard cuff sphygmomanometer. Minute ventilation (VE), breathing frequency (fR), tidal volume (VT), oxygen consumption (VO2), CO2 production (VCO2), RER, and end-tidal CO2 (PETCO2) will be obtained breath-by-breath and averaged over a 30-second period at rest and the last 30 seconds of each minute during exercise. In addition, heart rate (HR) and oxygen saturation (SaO2) will be obtained continuously using pulse oximetry. From these data, derived variables such as the VE/VCO2 ratio, oxygen pulse (VO2/HR) and an index of pulmonary capacitance (O2 pulse /[1/PETCO2]) are calculated at rest and during exercise. Ventilatory efficiency slopes (VE/VCO2 slope) [VE liter/min _ m (VCO2, liter/min) _ b], where m _ VE/VCO2 slope, and oxygen uptake efficiency slopes (OUES) [VO2, liter/min _ m (log10VE) _ b], where m _ OUES, are calculated using all exercise data points via least squares linear regression. Modified 3 minute step test: Each participant will perform a sub-maximal exercise test that consists of 2 minutes of resting baseline, 3 minutes of step exercise, and 1 minute of recovery. Breathing pattern, gas exchange (as described above), and heart rate will be monitored using a simplified gas analysis system (SHAPE Medical Systems, Inc, St. Paul, MN). Submaximal testing will be defined by respiratory exchange ratio (RER), and perceived exertion (RPE). An exercise RER of 0.9 and RPE of 12 to 13 on the Borg scale (range, 6 to 20) is considered to be a sub-maximal level. At the end of the first & second minute of step exercise, RER and RPE will be recorded and the step rate adjusted (a patient with a low RER (< 0.8) and RPE (< 8) would increase the step rate for the second minute, whereas a patient with a higher RER (> 0.85) and RPE (> 11) would maintain the same step rate). On completion of the 3-minute step exercise, recovery data will be collected for 1 minute.

   NCT ID:

   NCT01658982

   IRB Number:

   12-004215

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   Who can I contact for additional information about this study?

   Rochester: Kymberly Watt, MD 507-266-1586
                       
   
   
   

4. Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in Liver Transplant Recipients Rochester, MN View Summary
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   Prophylaxis Versus Preemptive Therapy for the Prevention of CMV in Liver Transplant Recipients

   Location:

   Rochester, MN

   Trial status:

   Open for Enrollment

   Why is this study being done?

   Title: Prophylaxis versus Preemptive Therapy for Prevention of CMV in High-Risk R-/D+ Liver Transplant Recipients ['CAPSIL' Study] Population: CMV seronegative recipients (18 years of age or older) of a liver transplant from a CMV seropositive donor (R-/D+) Phase: IV Number of Clinical Sites: 5 Study Duration: 5 years Subject Participation Duration: Until the closure of the study and not to exceed 5 years from enrollment. Description of Agent or Intervention: Oral Valganciclovir hydrochloride: 2-[(2-amino-6-oxo-6,9-dihydro-3H-purin-9-yl)methoxy]-3-hydroxypropyl (2S)-2-amino-3-methylbutanoate. Currently marketed as Valcyte ®. The primary objective is to compare prophylaxis versus preemptive therapy using valganciclovir for the prevention of CMV disease in R-/D+ liver transplant recipients Secondary objectives :To assess the two preventive strategies for: - Clinical outcomes (major bacterial, fungal and non-CMV viral infections, rejection, graft loss and mortality) - Hematologic toxicity (assessment of neutropenia and receipt of hematopoietic growth factor during study days 1-107) Study Design: This is a prospective, randomized, multicenter trial of preemptive therapy vs. prophylaxis for prevention of CMV disease in R-D+ liver transplant patients. Patients meeting study criteria and who have provided informed consent will be randomized within 10 days of transplant to receive in an open label design, either antiviral prophylaxis with valganciclovir 900 mg orally once daily or preemptive therapy (weekly monitoring for CMV viremia by plasma PCR) for 100 days post- randomization with initiation of oral valganciclovir 900mg orally twice daily at onset of CMV viremia and continued until plasma PCR is negative on two consecutive weekly PCR tests). Valganciclovir dosages will be adjusted for renal dysfunction. Study participants will be followed during the intervention period (100 days post randomization) and until 12 months post-transplant for CMV disease, toxicity, and clinical outcomes (opportunistic infections, rejection, graft loss and mortality). Estimated Time to Complete Enrollment: Approximately 3.5 years

   NCT ID:

   NCT01552369

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   Who can I contact for additional information about this study?

   Rochester: Raymund Razonable, MD 507-284-3747
                       Kristen Cornwell 507-266-8493