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Liver Transplantation clinical trials

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NCT ID: NCT00209196 Completed - Clinical trials for Kidney Transplantation

Quality of Life in Pediatric Transplant Recipients

Start date: May 2005
Phase: N/A
Study type: Observational

Adherence to medical regimens refers to what degree a patient chooses to follow the advice given by his/her healthcare provider. Good adherence typically involves behaviors such as the patient taking medication as directed and going to scheduled clinic appointments. As many patients often do not follow the advice of doctors as closely as suggested, many researchers have tried to find out the reasons behind patients being "non-adherent." This research has looked at medical conditions such as diabetes, cystic fibrosis, and asthma. More recently, researchers have started to look at adherence with children who have undergone solid organ transplantation. This is because about 50% of these children are to some degree non-adherent with their medical regimen. This comes at a costly price as ongoing non-adherence in pediatric transplant can lead to the child's body rejecting the new organ and even death. This study has been designed to look at the reasons that pediatric patients may choose to be non-adherent. This study will look at issues related to the patient (e.g., age, family support), related to the disease and regimen (e.g., length of illness, how complicated the regimen is), related to the medication (e.g., taste, side effects), related to their mind (e.g., memory problems, confusion), and related to their emotions (e.g., being depressed, anxious). The investigators will be looking at each regimen-related behavior, such as attending clinic appointments and will be asking each family about any barriers that make it difficult. The investigators hope that knowing these barriers will help them make interventions that fit the specific issues that each patient faces. Ultimately, doctors, transplant coordinators, and psychological professionals will be able to use this information to intervene early with families who report barriers that impact adherence.

NCT ID: NCT00195988 Completed - Clinical trials for Liver Transplantation

Comparison of Immunosuppression Protocols After LTx in Children

Start date: September 2002
Phase: Phase 4
Study type: Interventional

Open label, randomised, prospective, onecentre Investigator Driven Study: Comparison of two protocols of immunosuppression after liver Tx in children: A: Study group - FK506-MMF. Immunosupression protocol: Methylprednisolone 10 mg/kg intraoperatively i.v. FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses).MMF max. dosage 30 mg/kg/D p.o. day 0 through day 90. B. Control group - Tacrolimus, steroids. Immunosupression protocol: Methylprednisolone 10 mg/kg bm intraoperatively Children < 25kg bm: Methylprednisolone taper from 100 mg/D on day 0 to MP 10 mg on day 7 Children > 25kg bm: Methylprednisolone taper from 200 mg/D on day 0 to MP 20 mg on day 7 Week 2-4 Prednisone - 0,5-0,3 mg/kg/D; Week 4-12 Prednisone –0,3-0,2 mg/kg/D; Month 4-6 Prednisone 0,2 – 0,1 mg/kg/D Month 7 – Steroid withdrawal FK506 Day 0 or 1 orally (0,15 mg/kg/D in two doses). Primary end points: Number of rejections, number of steroid-resistant rejections. Secondary end points: Patients and graft survival Dyslipidemia one year after transplantation Hypertension one year after transplantation Hyperglycemia/Diabetes de novo one year after transplantation Renal function before Tx and 1 year after Tx

NCT ID: NCT00189826 Completed - Clinical trials for Liver Transplantation

A Study to Evaluate the Safety and Efficacy of FK506E (MR4) in Patients Undergoing Primary Liver Transplantation.

Start date: August 2004
Phase: Phase 3
Study type: Interventional

To evaluate and to compare efficacy and safety of a dual regimen with oral modified release tacrolimus FK506E (MR4) / steroids versus a dual regimen with oral tacrolimus FK506 / steroids in patients undergoing primary liver transplantation. It shall be demonstrated that FK506E (MR4) is non-inferior to FK506 with regards to the primary endpoint.

NCT ID: NCT00171743 Completed - Liver Transplant Clinical Trials

Efficacy and Safety of Cyclosporine Microemulsion in Diabetic Adult Stable Liver Transplant Recipients

Start date: April 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether the switch from tacrolimus to cyclosporine microemulsion benefits post-transplant diabetes management (in terms of glycogenic control and insulin dosage) in stable liver transplant recipients.

NCT ID: NCT00171509 Completed - Liver Transplant Clinical Trials

Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients

Start date: May 2004
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether cyclosporine microemulsion given once a day instead of twice a day benefits kidney function, blood pressure, lipid profile and glucose control in stable liver transplant recipients. The study also aims to identify the target ranges of levels of cyclosporine microemulsion in the blood.

NCT ID: NCT00170131 Completed - Clinical trials for Liver Transplantation

MMF Influence on HCV Viral Evolution After Liver Transplantation

Start date: September 2002
Phase: Phase 4
Study type: Observational

Samples from a large clinical trial comparing three immunosuppression regimens, two of which contained MMF, are used to identify the HCV viral quasispecies behaviour after liver transplantation

NCT ID: NCT00151593 Completed - Clinical trials for Liver Transplantation

Evaluation of Celsior® in Liver Transplant Preservation.

Start date: February 2002
Phase: Phase 2
Study type: Interventional

The aim of the study is to determine the efficacy and safety of a preservation solution in liver transplantation. Its efficacy will be compared to the efficacy of other currently used preservation solutions.

NCT ID: NCT00151580 Completed - Hepatitis C Clinical Trials

Treatment of Recurrent Hepatitis C After Liver Transplantation

TRANSPEG
Start date: February 2002
Phase: Phase 3
Study type: Interventional

In France, 50% of the hepatitis C virus carriers develop chronic clinical hepatitis, which may lead to cirrhosis and liver transplantation. Transplant infection by hepatitis C virus is constant after transplantation. This recurrence usually causes chronic liver disease, in 50 to 80% of the patients. The interest of a long-term treatment with ribavirin alone after transplantation has not been clearly demonstrated. The objective of our study is to evaluate the efficacy of ribavirin as a maintenance treatment after a one year interferon-α / ribavirin therapy on hepatitis C recurrence in the transplanted liver.

NCT ID: NCT00149994 Completed - Liver Transplant Clinical Trials

Cyclosporine A C-2h Monitoring Versus Tacrolimus C-0h Monitoring in de Novo Liver Transplant Recipients

Start date: December 2002
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determine whether cyclosporine A (in a micro emulsion formulation) monitored by sample taken 2 hour after oral dose (C-2h) will show equivalent or superior efficacy compared to tacrolimus monitored by pre-dose blood concentration (C-0h). In addition this study will assess the safety and tolerability of a cyclosporine A regimen based on C-2h monitoring in comparison to the standard tacrolimus regimen.

NCT ID: NCT00149942 Completed - Clinical trials for Kidney Transplantation

Conversion Trial From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) in Stable Transplanted Patients Suffering From Gastrointestinal (GI) Adverse Events While on Mycophenolate Mofetil Therapy (MMF) Therapy

Start date: October 2004
Phase: Phase 4
Study type: Interventional

This open, single arm, explorative study aims to investigate the evolution of gastrointestinal adverse events after switch from MMF to EC-MPS in organ transplanted patients suffering from gastrointestinal adverse events while on MMF therapy.