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Liver Failure clinical trials

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NCT ID: NCT01074645 Completed - Hepatitis B Clinical Trials

Randomized Controlled Trial of Tenofovir in Patients of Reactivation of Hepatitis B Presenting as Acute on Chronic Liver Failure

ACLF
Start date: November 2007
Phase: Phase 4
Study type: Interventional

Background: Reactivation of hepatitis B is a well-characterized syndrome marked by the abrupt reappearance or rise of hepatitis B virus (HBV) DNA in the serum of a patient with previously inactive or resolved HBV infection. Reactivation can be spontaneous, but is most commonly triggered by cancer chemotherapy, immune suppression, or alteration in immune function. Spontaneous acute exacerbation of chronic hepatitis B infection is seen with a cumulative probability of 15±37% after 4 years of follow-up.2 Significant number of patients of spontaneous acute exacerbation of chronic hepatitis B may present with very high ALT levels, jaundice and liver failure.3 This condition should be defined as acute-on-chronic liver failure (ACLF) according to a recent Asia-Pacific consensus recommendation. The short term prognosis of patients of spontaneous acute exacerbation of chronic hepatitis B leading to ACLF like presentation is extremely poor, with a mortality of 30-70% in different series.8,9,10 Liver transplantation has been the only definitive therapy available to salvage this group of patients. However ,this is not readily available and affordable. Another therapeutic option is antiviral therapy but has limited data. The efficacy of lamivudine was evaluated and compared by historical control but was not found to be beneficial.8,9,10 However ,a study from Taiwan showed a survival benefit in a subgroup of patients who were on lamivudine and had baseline bilirubin below 342 mmol/L (20 mg/dL).11 Tenofovir disoproxil fumarate (TDF) is a potent, rapidly acting, oral acyclic nucleotide analogue, reverse transcriptase inhibitor that has been shown to be highly effective in suppressing hepatitis B virus replication.12 Tenofovir has also shown excellent activity against HBV in both LAM- naïve and LAM-resistant patients.13,14. Its efficacy has not been evaluated in patients of reactivation of hepatitis B who present as ACLF Hypothesis: The investigators hypothesis that Tenofovir reduces the morbidity and mortality in patients with Spontaneous reactivation of hepatitis B by reducing HBV DNA.

NCT ID: NCT01071746 Recruiting - Liver Cirrhosis Clinical Trials

Predictive Utility of DASIMAR as a Prognostic Biomarker in Acute-on-chronic Liver Failure (ACLF)

DASIMAR
Start date: September 2008
Phase: N/A
Study type: Observational

Patients with acute on chronic liver failure have a risk of developing multiorgan failure and a high mortality. The current scoring systems defining the outcome of patients with acute decompensation of cirrhosis fail to identify patients that progress to Acute-on-chronic liver failure (ACLF). The aim of the study is to evaluate if one can identify these patients early on with the proposed biomarkers: dimethylarginines and ischemia modified albumin.

NCT ID: NCT01037959 Terminated - Cirrhosis Clinical Trials

Norfloxacin Therapy for Patients With Cirrhosis and Severe Liver Failure

NORFLOCIR
Start date: April 2010
Phase: Phase 3
Study type: Interventional

Patients with advanced cirrhosis have abnormal translocation of Gram-negative bacteria across the intestinal barrier and subsequent systemic inflammatory response. We hypothesized that this translocation may worsen the underlying liver disease. Thus, the aim of this trial was to assess the effects of the oral administration of norfloxacin (an antibiotic that suppresses intestinal Gram-negative bacteria) on the development of complications of cirrhosis.

NCT ID: NCT01036932 Recruiting - Clinical trials for Acute on Chronic Liver Failure

Granulocyte Colony Stimulating Factor(G-CSF) Therapy for Patients With ACLF

Start date: December 2008
Phase: N/A
Study type: Interventional

The purpose of the study is to determine whether Granulocyte Colony Stimulating factor(G-CSF) therapy is effective in the treatment of patients with Acute on chronic liver failure(ACLF). The investigators hypothesize that ACLF is a disease where severe hepatic impairment is accompanied by impaired hepatic regeneration. BMC mobilization using G-CSF therapy, or G-CSF therapy per se would increase the regenerative capacity of the liver and shall lead to clinical, biochemical and histological improvements in patients with ACLF.

NCT ID: NCT01022476 Completed - HIV Infection Clinical Trials

Raltegravir in Patients With End Stage Liver Disease and in Transplant Recipients

LIVERAL
Start date: May 2010
Phase: Phase 1/Phase 2
Study type: Interventional

This phase I/II, multi-center study is designed to determine the pharmacokinetic profile of Raltegravir in patients with end stage liver disease and to assess drug-drug interaction when Raltegravir is combined with immunosuppressive therapy in liver transplant recipients.

NCT ID: NCT01013194 Completed - Liver Cirrhosis Clinical Trials

Human Fetal Liver Cell Transplantation in Chronic Liver Failure

hFLCTx
Start date: February 2007
Phase: Phase 1/Phase 2
Study type: Interventional

The herein study consists in the transplantation of liver progenitor cells isolated from human fetal liver tissue with the aim of improving conventional liver therapy and broadening therapeutical options other than liver transplantation.

NCT ID: NCT00986648 Completed - Clinical trials for Hepatic Encephalopathy

A Multi-Center Group to Study Acute Liver Failure in Children

Start date: January 2000
Phase: N/A
Study type: Observational

The PALF study group began with 20 sites and now continues with 12 sites (11 in the United States and 1 in Canada) in the new funding period. The primary objective of the Pediatric Acute Liver Failure (PALF) study is to collect, maintain, analyze, and report clinical, epidemiological, and outcome data in children with ALF, including information derived from biospecimens.

NCT ID: NCT00968591 Completed - Clinical trials for Hepatic Insufficiency

Pharmacokinetics of Everolimus in Subjects With Hepatic Insufficiency

Start date: November 2009
Phase: Phase 1
Study type: Interventional

This clinical pharmacology research study will assess the safety and pharmacokinetics of the drug everolimus in patients with impaired hepatic function as compared to healthy volunteers.

NCT ID: NCT00956891 Completed - Liver Failure Clinical Trials

Therapeutic Effects of Liver Failure Patients Caused by Chronic Hepatitis B After Autologous MSCs Transplantation

Start date: May 2005
Phase: Phase 1/Phase 2
Study type: Observational

The study aimed to investigate the short-term efficacy and long-term prognosis of liver failure patients caused by hepatitis B after single transplantation with autologous marrow mesenchymal stem cells (MMSCs). Liver failure inpatients caused by hepatitis B were recruited and received the same medical treatments, among whom some patients underwent single transplantation with autologous MMSCs and other patients with matched age, gender and biochemical indexes [alanine aminotransferase (ALT), albumin (ALB), total bilirubin (TBIL), prothrombin time (PT) and Model for End-stage Liver Disease (MELD) ] were in control group. A total of 120 ml bone marrow were obtained from patients, diluted and separated. Then MMSCs suspension were slowly transfused into the liver through the proper hepatic artery by interventional procedures. The levels of ALB, TBIL, PT and MELD score of patients in translation group were compared with those in control group. In 3 ~ 48 months of follow-up, differences in long-term outcomes such as incidence of HCC (hepatocellular carcinoma) and mortality between two groups were compared.

NCT ID: NCT00950508 Completed - Acute Liver Failure Clinical Trials

A Study of the Effect of Plasmaexchange in Patients With Acute Liver Failure

Start date: June 1998
Phase: N/A
Study type: Interventional

The aim of this study is to examine if high-volume plasma exchange has a positive effect on mortality in patients with acute liver failure.