Active clinical trials for "Hepatic Insufficiency"

Study population: Patients admitted or seen in OPD (Out Patient Department), Department of Hepatology. Study design- Prospective Randomized Controlled Trial. Study period-January 2016 to May 2017 Intervention- Subjects will be randomized into 3 groups Group A subjects will receive ω3 PUFA (Polyunsaturated Fatty Acids) (10% Omegavan 100 ml). Group B- will receive ω6 PUFA (Polyunsaturated Fatty Acids) (10% Intralipid 100 ml). Group C -Placebo group Monitoring and assessment- :- The following tests will be done in these patients:- Complete clinical examination. Serum electrolytes- sodium, potassium, calcium, magnesium, phosphate levels BUN (Blood Urea Nitrogen) Serum free fatty acid levels Lipid profile. Arterial ammonia Arterial lactate Blood sugar and serum insulin levels

Background: Acute-on-chronic liver failure (ACLF) is a syndrome characterized by acute deterioration in the setting of chronic liver disease associated with high short-term mortality. Currently, there is no specific treatment for patients with ACLF. Our previous results showed that Chinese herbal medicine (CHM) could reduce the mortality rate and the incidence of complications of ACLF effectively. In this study, we aim to conduct the multi-center randomized controlled trial to evaluate the effect of unified CHM formulas and provide propagable and high-level evidence for clinical practice. Methods/design: This is a prospective, multicenter, centrally randomized controlled trial. Five hundred and ten patients diagnosed with HBV-related ACLF will be allocated in a 1:1 ratio to SMT group (standard medical therapy) and CHM group (CHM and SMT). The primary outcome is the transplant-free mortality rates at week 4, 8, 12, 24 and 48. Secondary outcomes include (1) the incidence of adverse reactions, (2) influence on liver function, (3) the incidence of serious complications and (4) the level of inflammatory cytokines. Discussion: The effectiveness and safety of CHM formulas are assessed in the treatment of ACLF.

Acute-on-chronic liver failure (ACLF) is a syndrome associated with a high short- term mortality. Early identification of patients at high risk is important to determine emergency for transplantation and prioritize the need for intensive care unit. Unbalanced systemic inflammatory response is closely associated with mortality in ACLF patients. This systemic inflammatory response in ACLF increases liver and splenic stiffness stiffnes, which can be detected by transient elastography. Very few studies have been done in past evaluating liver and splenic stiffness as prognostic tool in patients of ACLF. These studies have taken only single value of liver and splenic stiffness as prognostic tool. No follow up study have yet been done assessing acute change in liver and splenic stiffness in ACLF. In this study, we hypothesize that acute change in liver and splenic stiffness at 7th & 14 th day predicts outcome in ACLF patients. With this study, we aim to evaluate whether acute changes in liver and splenic stiffness at 7th & 14th day predicts outcome at 3 months in patients of ACLF.

This Phase 2a clinical study is designed to provide data on OCR-002 in patients with acute liver failure/acute liver injury (ALF/ALI) in regard to: safety and tolerability; metabolism of the compound to glutamine and phenylacetylglutamine (PAGN); its effect on circulating ammonia levels and neurological function in patients with and without impaired renal function after continuous infusion at different infusion rates. Subjects will receive up to 120 hours (5 days) of drug infusion, followed by a 30 day follow-up visit post infusion. It is anticipated that this early safety and tolerability study, with appropriate PK/PD data, will lead to a development program for the use of OCR-002 in the treatment of hyperammonemia either due to ALF or possibly other liver conditions. The hypotheses are: Treatment with OCR-002 is safe and tolerable in patients with acute liver failure/acute liver injury due to acetaminophen overdose or drug-induced liver injury, autoimmune hepatitis, viral hepatitis or indeterminate etiologies. A dose of 10-20g/24h (0.42-.83g/h) will achieve steady state plasma concentrations within 6-12h with little additional accumulation in the ALI/ALF setting. Treatment with OCR-002 will reduce ammonia and improve neurological function in patients with acute liver failure/severe acute liver injury.

The primary purpose of this study is to help answer the following research questions: To evaluate how much of the study drug (LY2605541) is in the blood of participants with varying degrees of liver impairment compared to those with normal liver function To assess the safety of LY2605541 and any side effects that might be associated with it

Study to assess the effects of varying degrees of renal dysfunction and hepatic insufficiency on the single-dose pharmacokinetics of nevirapine and nevirapine metabolites in order to establish an appropriate dose and/or dosing frequency for renally- and hepatically-impaired patients

The main objective of this study is to assess the effect of mild, moderate and severe hepatic impairment on the pharmacokinetics, safety and tolerability of BI 10773 following oral administration of BI 10773 as a single dose.

This study will evaluate the effects of mild and moderate impairment of hepatic function on the single-dose pharmacokinetics, safety and tolerability of AG-013736.

The purpose of this study is to characterize the pharmacokinetics (blood levels) of trabectedin after administration to patients with advanced malignancies and hepatic (liver) dysfunction.

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.