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Liver Diseases clinical trials

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NCT ID: NCT01437969 Completed - Liver Disease Clinical Trials

Pharmacogenomics Study on IL28B Genetic Variants in Italian Patients With HCV Infection naïve to Treatment.

Start date: September 2011
Phase:
Study type: Observational

More than 1.5 millions individuals are infected with HCV in Italy. They are at risk to develop related morbidity and mortality from cirrhosis and hepatocellular carcinoma, unless the evolution of their disease is halted by treatment-induced HCV RNA clearance. Indeed, it is well recognized that a curative antiviral treatment, leading to HCV RNA undetectability 24 weeks after the end of therapy, may prevent the occurrence of complications of HCV chronic liver disease. Several pre-treatment host and viral factors have been associated with the outcome of pegylated Interferon and Ribavirin treatment. These predictors are relevant as the ability to identify patients with the highest likelihood of achieving HCV RNA clearance may increase the number of patients who agree to be treated and who maintain their adherence to treatment. Several pre-treatment predictors as HCV genotype, HCV viral load, age, gender, body mass index, stage of fibrosis and race are very well recognized and have been used for many years during the treatment decision-making process. Based on studies of viral kinetics, HCV RNA undetectable at week 4 on treatment has been shown to represent the best on treatment predictor of response. In addition to these well known factors, very recently, a single nucleotide polymorphism (SNP) upstream of the gene IL28B on chromosome 19, coding for IFN-lambda 3 has been identified as associated with both spontaneous and treatment induced HCV RNA clearance. We have developed the molecular technique needed to evaluate this polymorphism in our laboratory. This technical process was a consequence of the genetics expertise of our research Institute. We have also performed a valuable comparison of the different methods to evaluate this polymorphism. Comparison of different technologies allow us to know the rate of variability between the different assays used. With this methodology we have evaluated "a posteriori" patients previously enrolled in Randomized Controlled Trial. The results of these studies confirmed the association between IL28B CC allele and a favorable outcome of HCV infection in our geographic area (Mangia et al Gastroenterology 2010; Mangia et al Hepatology 2010, AASLD presentation). We are now interested in prospective evaluation of patients referring to our center at the aim of understanding whether there are differences in the rates of IL28B frequencies in patients with different HCV genotypes. In fact, we hypothesize that the frequency of IL28B might be different according with different HCV genotypes and that this difference may explain the different rates of response to antiviral treatment reported in patients with HCV infection. Since we lead a collaborative group of hepatologists named AL-LIVER operating in Puglia, Lazio, Basilicata, Sicilia and Campania regions in Italy we would like to extend this evaluation to our collaborative group to explore in a large number of patients whether the prevalence of CC, CT and TT genotypes is inversely associated with HCV G1, 4, 3 and 2.

NCT ID: NCT01429779 Recruiting - Liver Diseases Clinical Trials

The Orange-III Trial: Optimised Recovery With Movicol® Preoperatively Within an Enhanced Recovery Programme

Start date: July 2012
Phase: Phase 4
Study type: Interventional

The aim of this study is to accelerate recovery after liver surgery by enhancing intestinal passage through the preoperative use of Movicol. Hypothesis The use of Movicol® during one week prior to partial liver resection combined with the Enhanced Recovery After Surgery (ERAS®) programme accelerates functional recovery by promoting early return of gastro-intestinal function, defined as the passage of stools and early oral intake.

NCT ID: NCT01425567 Approved for marketing - Liver Disease Clinical Trials

Compassionate Use of IV Fish Oil for Parenteral Nutrition (PN) Liver Injury

Omegaven
Start date: n/a
Phase:
Study type: Expanded Access

To establish a process by which critically ill infants with parenteral nutrition-associated liver disease can receive a fish oil-based intravenous lipid emulsion (Omegaven®) for compassionate use when no satisfactory alternative treatments are available.

NCT ID: NCT01423708 Recruiting - Liver Cirrhosis Clinical Trials

Everolimus in de Novo Liver Transplantation: a Multicentre Randomized Study

EPOCAL
Start date: February 2010
Phase: Phase 2
Study type: Interventional

Safety and Efficacy of Everolimus in adult de novo liver transplant recipients.

NCT ID: NCT01410123 Completed - HIV Clinical Trials

Integrated Stepped Care for Unhealthy Alcohol Use in HIV

Start date: January 2013
Phase: N/A
Study type: Interventional

The study is a series of 3 linked randomized clinical trials of 6 month duration, with a total of 12 month follow-up, to evaluate the effect of Integrated Stepped Care on drinking outcomes and HIV biologic markers (including VACS index) in HIV-infected patients with unhealthy alcohol use.

NCT ID: NCT01407666 Completed - Pain Clinical Trials

Comparison Between Epidural and Bilateral Paravertebral Blocks in Liver Resection

Start date: August 2010
Phase: N/A
Study type: Interventional

This prospective, randomized study is intended to assess the efficacy and safety of bilateral continuous paravertebral blocks compared to continuous epidural block for open liver resection. Hypotheses: Bilateral paravertebral blocks are: 1) equally effective in controlling the perioperative pain; and 2) safe, with less frequent complications following open liver resection when compared to continuous epidural block.

NCT ID: NCT01394497 Completed - Liver Diseases Clinical Trials

Use of N-Acetylcysteine During Liver Procurement

Start date: December 2006
Phase: Phase 2
Study type: Interventional

Randomized prospective study on the impact on the post-LT outcome by the infusion of N-acetylcysteine (NAC) during the liver procurement procedure, as an anti-oxidant agent to reduce the ischemia-reperfusion damage of organs for liver transplantation (LT).

NCT ID: NCT01390766 Completed - Liver Diseases Clinical Trials

Drug Use Investigation for IMURAN (Azathioprine) Tablet (Hepatic Transplantation)

Start date: August 2002
Phase: N/A
Study type: Observational

This post-marketing surveillance (PMS) study is designed to investigate the efficacy and safety of azathioprine tablets in Japanese subjects whom liver transplantation is performed.

NCT ID: NCT01381432 Completed - Liver Diseases Clinical Trials

Special Drug Use Investigation for IMURAN (Azathioprine) Tablet (Pulmones Transplantation)

Start date: December 2004
Phase: N/A
Study type: Observational

This post-marketing surveillance study is to investigate the efficacy and safety of azathioprine tablets in subjects whom lung transplantation is performed.

NCT ID: NCT01370148 Completed - Liver Disease Clinical Trials

A Study to Assess the Effect of Severe Hepatic Impairment on the Pharmacokinetics of Intravenous Conivaptan

Start date: April 2011
Phase: Phase 1
Study type: Interventional

The purpose of this study is to assess the pharmacokinetics and safety of a 48-hour continuous infusion of conivaptan in subjects with severe liver impairment compared to subjects with normal liver function.