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Liver Diseases clinical trials

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NCT ID: NCT00206076 Completed - Liver Disease Clinical Trials

Mycophenolate Mofetil Immunosuppression Without/With Reduced Dose Calcineurin Inhibitor Long After Liver Transplantation

Start date: August 2006
Phase: Phase 4
Study type: Interventional

The purpose of the study is to assess the safety and efficacy of mycophenolate mofetil alone, or with reduced dose cyclosporine (CsA) or tacrolimus, for immunosuppression long-term after liver transplantation, in an attempt to reduce the potential side effects from using cyclosporine or tacrolimus.

NCT ID: NCT00162058 Completed - Liver Disease Clinical Trials

A Phase II Study of DMP 115 to Assess Focal Liver Lesions

Start date: March 2004
Phase: Phase 2
Study type: Interventional

To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.

NCT ID: NCT00148031 Completed - Hepatitis C Clinical Trials

Improving Hepatitis C Treatment in Injection Drug Users

Start date: September 2003
Phase: Phase 4
Study type: Interventional

The overall goal of the research project is to improve the outcome of medical care for injection drug users (IDUs) with Hepatitis C viral (HCV) infection. Hypothesis: An intervention designed to improve the rate of HCV treatment completion and sustained virologic response (SVR) in IDUs will increase access by integrating HCV medical care into a substance abuse treatment program.

NCT ID: NCT00105235 Completed - Clinical trials for Liver Transplantation

Immune System Suppression With Alemtuzumab and Tacrolimus in Liver Transplantation Patients

TILT
Start date: June 2005
Phase: Phase 2
Study type: Interventional

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 recipient's health after liver transplantation in patients with end-stage liver disease, and whether gradual tapering of tacrolimus treatment is safe for these patients.

NCT ID: NCT00078403 Completed - HIV Infections Clinical Trials

Pegylated Interferon Alfa-2a Maintenance Therapy and Liver Disease Progression in People Infected With Both HIV and Hepatitis C Virus (HCV)

Start date: July 2004
Phase: Phase 2
Study type: Interventional

Infection with both HIV and hepatitis C virus (HCV) may result in serious and sometimes fatal liver disease. The purpose of this study was to test the effectiveness of long-term pegylated interferon alfa-2a (PEG-IFN) and ribavirin treatment in slowing liver disease progression in people infected with both HIV and HCV.

NCT ID: NCT00074386 Completed - HIV Infections Clinical Trials

Kidney and Liver Transplantation in People With HIV

Start date: October 2003
Phase: N/A
Study type: Observational

With improved anti-HIV drug therapy, HIV infected patients are now living longer. These patients are at risk for liver and kidney failure and may need organ transplants. However, little is know about the safety and effectiveness of organ transplants in patients with HIV. This study will evaluate organ transplantation in HIV infected patients undergoing liver and kidney transplants.

NCT ID: NCT00063648 Completed - Liver Disease Clinical Trials

Detection and Cytotoxic T Lymphocyte Therapy of Post-Transplant Lymphoproliferative Disorder After Liver Transplant

Start date: May 2002
Phase: Phase 1
Study type: Interventional

Despite advances in medical and gene therapy, orthotopic liver transplantation remains the only definitive therapeutic option for children with end-stage liver disease. Recent advances in pre-, intra-, and early post-transplant care have resulted in a dramatic improvement in survival of the pediatric liver transplant patient. The broad long-range goal of our research program is directed at enhancing the patient's long-term survival. Our primary focus relates to obligate life-long immunosuppression, with its inherent complications including severe infection and development of cancer. These two complications come together in a single disease, Epstein-Barr Virus (EBV)- associated post-transplant lymphoproliferative disorder (PTLD). EBV, a latent human lymphotrophic herpes virus infects and immortalizes B cells. Primary infection usually occurs via salivary exchange and results in a mild, self-limited illness followed by life-long EBV-specific T cell controlled EBV latency. T cell-based immunosuppression prevents allograft rejection, however, it also suppresses cytotoxic T lymphocyte (CTL) function, generating an environment in which EBV-infected cells can proliferate. Patients receiving life-long T cell-based immunosuppression have an increased risk of developing PTLD due to their inability to produce normal immunoregulatory responses. This disease is particularly devastating to the pediatric patient as its incidence is at least 4-fold greater than in the adult liver transplant patient population. In fact, PTLD is the number one cause of death following pediatric liver transplantation. At this time, there is no definitive method of prospectively detecting, diagnosing, or treating PTLD, and current treatment protocols place the liver allograft and patient at risk. Therefore, a diagnostic tool that is both sensitive and specific, and a treatment strategy with low toxicity are greatly needed to decrease the morbidity and mortality suffered by the pediatric liver transplant patient with PTLD. Our proposed studies will support our hypothesis that the combination of a persistently elevated EBV load in the setting of a diminished immune response to EBV will be an early risk indicator associated with PTLD development, and that pre-emptive treatment utilizing autologous adoptive EBV-specific CTL immunotherapy will provide a low toxicity treatment option.

NCT ID: NCT00063622 Completed - Liver Diseases Clinical Trials

Pioglitazone vs Vitamin E vs Placebo for Treatment of Non-Diabetic Patients With Nonalcoholic Steatohepatitis (PIVENS)

PIVENS
Start date: January 2005
Phase: Phase 3
Study type: Interventional

The purpose of this study is to determine if therapy with pioglitazone or vitamin E will lead to an improvement in liver histology in non-diabetic adult patients with non-alcoholic steatohepatitis (NASH).

NCT ID: NCT00058890 Completed - Cirrhosis Clinical Trials

Gabapentin to Treat Itch in Patients With Liver Disease

Start date: November 2000
Phase: Phase 3
Study type: Interventional

In this study, the effect of the medication gabapentin to treat itching secondary to liver disease is being studied. There are some funds to cover travel expenses for patients who are not from New York (NY). Gabapentin is approved to treat seizures in human beings. In this study, patients with liver disease who meet inclusion criteria are admitted to the research hospital of the New York Presbyterian Hospital to record scratching behavior by the use of a machine designed for that purpose. Blood work will be obtained. After completion of recording, patients are assigned by chance to receive active medication or placebo (a capsule that does not contain active medication). The patients will come to the outpatient office of the research hospital 2 weeks into the study for an interview and blood work. After 4 weeks, patients are readmitted to the hospital to record scratching behavior. After data are collected, the code is broken, if patient had been on inactive drug, active drug will be supplied as per protocol for 4 weeks. Blood work will be obtained. If patient had been randomized to active medication, the study will provide one week supply of drug. After that, the referring physician, with whom the study was previously discussed, could prescribe the medication as it is available.

NCT ID: NCT00011284 Completed - Liver Diseases Clinical Trials

Mechanisms of Inflammatory Liver Injury

Start date: n/a
Phase: N/A
Study type: Observational

White blood cells can cause liver damage if they inappropriately accumulate in the liver in large numbers. Such an event can occur if an individual's blood is exposed to endotoxin, a substance released from the cell walls of many species of bacteria. The purpose of this study is to isolate neutrophils, an important white blood cell, from the blood of normal volunteers, and put them in tissue culture with isolated liver cells. The experiments will determine how endotoxin can increase the ability of neutrophils to damage liver cells. All studies supported by this grant will be done with isolated cells in tissue culture. This experimental model will reveal possible mechanisms that can in the future be evaluated in human diseases such as bacterial sepsis.