Clinical Trials About "MediciNova Announces Approval Second Phase Protocol NASH Which" RSS

00:46 EST 16th December 2018 | BioPortfolio

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Showing "MediciNova Announces Approval Second Phase Protocol NASH Which" Clinical Trials 1–25 of 20,000+


Phase 1 Pharmacokinetic Study Of CP-945598 In Patients With NASH

CP-945598 is a potent and selective Cannabinoid-1 (CB1) receptor antagonist currently being developed for the treatment of obesity. CP-945598 is also being considered as a potential treatment for non-alcoholic steatohepatitis (NASH). This study will investigate the steady-state safety, toleration and pharmacokinetics of multiple oral dose administration of CP-945598. Results will be used to estimate the pharmacokinetic characteristics in NASH patients and underwrite the safe...

Impact of Text Messaging in the Management of Non-alcoholic Fatty Liver Disease

This randomized study aims at examining the impact of text messaging in the management of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH), a disease frequently associated with obesity and varying components of metabolic syndrome including diabetes mellitus, hypertension, and dyslipidemia. With rising incidence of obesity in the US, NAFLD and NASH are rapidly increasing with currently the second etiology for liver transplantation in the US. The...

Protocol for the Assessment of Variability in Histology and Gene Expression in Bariatric Surgery Patients.

It is known that a vast majority of patients seeking a bariatric surgery weight reduction procedure have non-alcoholic fatty liver disease (NAFLD), while a smaller subset of patients within this group have a more serious liver problem known as nonalcoholic steatohepatitis (NASH). NASH is a serious liver disease that can lead to cirrhosis, liver failure and ultimately liver transplantation. The purpose of this study is to explore the effects of bariatric surgery on the progres...

Different Doses of BI 1467335 Compared to Placebo in Patients With Clinical Evidence of NASH

The primary objective of this study is the proof of mechanism and support of dose finding, together with the safety evaluation in patients with clinical evidence of NASH. To gain further insight into clinical effects of AOC3 inhibition on NASH further exploratory analyses of biomarkers related to NASH and liver fibrosis will be performed. This will include the effect of BI 1467335 on reduction of secondary biomarker endpoints (ALT, AST, AP, γ-GT and CK18 fragments). Safety wi...

A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver Disease (NAFLD) or Nonalcoholic Steatohepatitis (NASH)

TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFLD or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients with NAFLD or NASH within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

Randomized Global Phase 3 Study to Evaluate the Impact on NASH With Fibrosis of Obeticholic Acid Treatment

The primary objective of this study is to evaluate the effect of Obeticholic Acid treatment compared to placebo on liver-related clinical outcomes in patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) with liver fibrosis.

Safety, Tolerability, Pharmacokinetics and Efficacy of LMB763 in Patients With NASH

The purpose of the present study is to assess the effects of LMB763 with respect to safety, tolerability, and on markers of liver inflammation in patients with NASH

Bariatric Embolization of Arteries for the Treatment of Nonalcoholic Steatohepatitis (BEAT-NASH)

Obesity is an epidemic in the US. With progression of obesity, Nonalcoholic steatohepatitis (NASH) has been a growing public health issue. Presently there is no cure for NASH.Prevention of progression of fibrosis in NASH is crucial, as they are at a high risk for cirrhosis and may need liver transplant. Recent studies have shown that blocking blood vessels to a particular portion of the stomach (bariatric or left gastric artery embolization) can temporarily decrease levels of ...

Efficacy and Safety of MT-3995 in Patients With Non-Alcoholic Steatohepatitis(NASH)

The purpose of this study is to investigate the efficacy, safety, tolerability and pharmacokinetics of multiple oral administration of MT-3995 in patients with NASH.

A Pilot Study to Assess the Safety of Oral Insulin in Patients With Nonalcolholic Steatohepatitis (NASH)

This is an open, pilot study using the oral ORMD-0801 insulin formulation in patients with NASH and confirmed type 2 DM or pre-diabetes. The study will consist of a Screening, placebo run-in, treatment phase and end-of-study phase.

A Study to Evaluate Seladelpar in Subjects With Nonalcoholic Steatohepatitis (NASH)

A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Activity of Seladelpar in Subjects with Nonalcoholic Steatohepatitis (NASH)

Balanced Knee System Clinical Protocol for IRB Approval

The protocol will define the clinical study for Ortho Development's Balanced Knee® System (BKS) for subsequent review and approval by an Institutional Review Board (IRB).This clinical study will compare the clinical outcomes of BKS to currently marketed devices.

Spironolactone Therapy In Women With NASH

Nonalcoholic steatohepatitis (NASH), or fat-related liver inflammation and scarring is projected to be the leading cause of cirrhosis in the United States (U.S.) within the next few years. Women are at disproportionate risk for NASH, with approximately 15 million U.S. women affected. There is an urgent need to understand risk factors for NASH and its progression in women, and sex hormones may provide a missing link. The investigator's preliminary data support a detrimental rol...

An Expanded Treatment Protocol of Panobinostat in Combination Therapy for Relapsed, and Relapsed and Refractory Multiple Myeloma

The purpose of this study is to provide oral panobinostat (PAN) treatment to relapsed or relapsed and refractory multiple myeloma patients who are without satisfactory treatment alternatives prior to the commercial availability* and reimbursement of panobinostat during the regulatory approval process. This protocol will acquire additional safety data on the use of panobinostat in combination with bortezomib (BTZ) and dexamethasone (Dex) in patients with relapsed or relapsed and...

Orlistat (Xenical) in the Treatment of Overweight Patients With Nonalcoholic Steatohepatitis (NASH)

The purpose of this study is to determine if orlistat (Xenical) therapy in overweight patients with NASH leads to enhanced weight loss over time, with subsequent improvement in the underlying necroinflammatory and fibrotic changes that are typical of NASH.

EUS Guided Core Liver Biopsy and IGB Placement for the Diagnosis and Management of NASH and Obesity

This study is designed to investigate the impact of weight loss achieved with the IGB on NASH with early fibrosis in a select cohort of patients with obesity preselected to have a high pre-test probability of having NASH with early fibrosis based on MRE-Hepatogram. In addition, this study will explore potential non-invasive imaging criteria for NASH and early fibrosis using EUS-Elastography.

Pentoxifylline/Nonalcoholic Steatohepatitis (NASH) Study: The Effect of Pentoxifylline on NASH

The purpose of this study is to explore the potential benefit of the medication, pentoxifylline, for the treatment of NASH.

Immunomediated Non-alcoholic SteaTohepatitis; Prevalence and Characterization. INSTInCT Study

NAFLD is a common comordidity in patients with IMID, including inflammatory bowel disease and psoriasis. Nevertheless, the prevalence of NAFLD and NASH in the IMID population is not clear, and the risk factors are not completely understood. Interestingly, NASH and most of IMIDs share main molecular and immunological mechanisms of disease, as the inflammatory pathways depending on TNFa or imbalance in T cell subtypes like Th17/Treg. This common pathogenesis may explain, at ...

Pentoxifylline in Patients With Nonalcoholic Steatohepatitis

One third of the population in the United States has nonalcoholic fatty liver disease (NAFLD). Nonalcoholic steatohepatitis (NASH), the progressive form of NAFLD, can lead to cirrhosis.Currently, there is no proven therapy for patients with NASH. Our core hypothesis is that therapy of patients with NASH with pentoxifylline for one year will result in improvement of biochemical parameters of liver disease and hepatic histology. The focus of this proposal is on the effectiveness ...

Treating Nonalcoholic Steatohepatitis (NASH) With Metformin

Nonalcoholic Steatohepatitis (NASH) is associated with progressive liver disease, fibrosis, and cirrhosis. Although the cause of NASH is unknown, it is often associated with obesity, type 2 diabetes, and insulin resistance. At present, there are no approved treatments for NASH patients, but an experimental approach has focused on improving their insulin sensitivity. Metformin is one of the most commonly used medications for the treatment of diabetes. The purpose of th...

STELLARIS: Phase 3 Study for the Efficacy and Safety of CVC for the Treatment of Liver Fibrosis in Adults With NASH

The STELLARIS study will be conducted to confirm the efficacy and safety of cenicriviroc (CVC) for the treatment of liver fibrosis in adult subjects with NASH.

A Randomized Controlled Study Evaluating Bariatric Surgery as a Treatment for Severe NASH With Advanced Liver Fibrosis in Non-severe Obese Patients

The aim of the study is to demonstrate the superiority of bariatric surgery on the disappearance of NASH without worsening of fibrosis in comparison to medical standard treatment in obese patients (35 kg/m² > BMI ≥ 30 kg/m²) with NASH complicated of advanced fibrosis (F3 and F4 fibrosis grade according to Brunt score).

An Efficacy and Safety Study of Rimonabant for Treatment of Nonalcoholic Steatohepatitis (NASH) in Patients Without Diabetes

The purpose of this study is to assess the effect of rimonabant treatment on the histological features of NASH.

Effect of DMR in the Treatment of NASH

Non-alcoholic fatty liver disease (NAFLD) is a frequent disease affecting up to 25% of the USA population, 2-44% in Europe and up to 42,6-69,5% in patients with type 2 diabetes. It is a disease that could progress from simple steatosis to non-alcoholic steatohepatitis (NASH), hepatic cirrhosis and hepatocarcinoma. NASH is part of continuum of metabolic syndrome and constitutes a serious public health concern manifesting by premature cardiovascular disease, end stage diabetes co...

Weight Management in Nonalcoholic Steatohepatitis

Nonalcoholic steatohepatitis (NASH) is one of the most common chronic liver diseases. The cause of NASH is not completely understood and currently there is no effective treatment for this disease. An effective approach to treatment is needed since without treatment this disease may progress to fibrosis and cirrhosis. Obesity is one of the most important risk factors for NASH and weight reduction is generally recommended as an initial step in its management. However, there are v...

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