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Nonalcoholic Steatohepatitis clinical trials

View clinical trials related to Nonalcoholic Steatohepatitis.

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NCT ID: NCT01679197 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy

Start date: October 8, 2012
Phase: Phase 2
Study type: Interventional

This study involves research about an investigational medicine called metreleptin. The reason for this study is to find out how metreleptin can improve non-alcoholic steatohepatitis or nonalcoholic fatty liver disease associated with lipodystrophy, a rare disorder associated with abnormal loss of the body's fat tissue. In this study, metreleptin is considered to be investigational for the treatment of lipodystrophy. Metreleptin will be given via injections under the skin. We plan to continue therapy for a period of one year and evaluate the change in liver disease by a liver biopsy. We will also follow the metabolic parameters (e.g. blood cholesterol, liver function, insulin resistance) and body composition characteristics (e.g. the pattern of fat distribution in the body).

NCT ID: NCT01466894 Withdrawn - Clinical trials for Nonalcoholic Steatohepatitis

Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis

Start date: December 2012
Phase: Phase 2
Study type: Interventional

This is a multi-center, randomized, placebo-controlled, double-blind, dose-selection, multiple dose administration study comprising three groups, with up to 40 patients in each active treatment and placebo group. Patients with biopsy proven nonalcoholic steatohepatitis (NASH) and elevated liver enzymes will be randomized to undergo a liver MRI scan and to receive Imm 124-E or placebo for 24 weeks. During this period, patients will be followed for clinical and laboratory effects. At the end of 24 weeks of treatment, patients will undergo a second liver MRI scan. Patients will be followed for an additional 4 weeks for safety after completion of treatment.

NCT ID: NCT01399645 Completed - Type 2 Diabetes Clinical Trials

Study of Liraglutide Versus Insulin on Liver Fat Fraction in Patients With Type 2 Diabetes

LIRAINS
Start date: May 2011
Phase: Phase 2
Study type: Interventional

This study is conducted to test the hypothesis that in type 2 diabetic adults with fatty liver who are resistant to metformin, treatment with liraglutide in combination with metformin will cause an absolute reduction in liver fat superior to insulin-metformin treatment within a 3-month period, as measured by magnetic resonance imaging (MRI).

NCT ID: NCT01355575 Terminated - NAFLD Clinical Trials

Rifaximin in Fatty Liver Disease

RiFL
Start date: May 2011
Phase: Phase 4
Study type: Interventional

TITLE Rifaximin in Fatty Liver Disease (RiFL) DESIGN Open-label pilot study HYPOTHESIS Reduction in gut flora by the antibiotic Rifaximin reduces hepatic inflammation in Non-Alcoholic Steatohepatitis (NASH). AIMS To provide proof-of-concept data on the therapeutic potential of gut flora modification in NASH OUTCOME MEASURES Primary: • Change in serum ALT from baseline by 25 IU/L or to within normal range after 6 weeks of Rifaximin therapy Secondary: - Change in intrahepatic triglyceride, estimated by in vivo proton magnetic resonance spectroscopy (1H MRS) - Change in hepatic insulin resistance, estimated by the hyperinsulinaemic euglycaemic clamp - Changes to the faecal bacterial microbiome assessed by faecal DNA pyrosequencing and fluorescent in-situ hybridisation (FISH) - Differences in urinary metabolic profiles as assessed by high-resolution proton nuclear magnetic resonance spectroscopy POPULATION Patients with biopsy-confirmed non-alcoholic steatohepatitis and persistently raised serum aminotransferase levels TREATMENT The non-absorbable antibiotic Rifaximin DURATION This was an open-label study of Rifaximin (Normix, Alfa Wasserman S.p.A, Bologna, Italy) 400mg twice daily for six weeks followed by a further six weeks observation period during which patients received standard care.

NCT ID: NCT01260246 Terminated - Type 2 Diabetes Clinical Trials

Sitagliptin for the Treatment of Non-alcoholic Steatohepatitis in Patients With Type 2 Diabetes

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

This is a randomized, double-blind, placebo-controlled trial evaluating the impact of sitagliptin therapy in patients with concomitant type 2 diabetes and non-alcoholic steatohepatitis (NASH) on improving liver disease based on biopsy results. The effect of sitagliptin on other measures such as hormones modifying insulin release and sensitivity (termed adipocytokines), fat distribution, and biomarkers of cardiovascular risk will also be evaluated.

NCT ID: NCT01237119 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Liraglutide Efficacy and Action in Non-Alcoholic Steatohepatitis

LEAN
Start date: August 2010
Phase: Phase 2
Study type: Interventional

The purpose of this study is to investigate whether 48 weeks treatment with once-daily injections of liraglutide improves liver disease (liver fat, inflammation and scarring) and related metabolic parameters in overweight patients with nonalcoholic steatohepatitis, enough to warrant further investigation.

NCT ID: NCT01205087 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome

Start date: September 2010
Phase: Phase 2
Study type: Interventional

This clinical study is designed to evaluate the safety and immune modulatory effects of oral administration of the study drug anti-CD3 monoclonal antibody (MAb) to subjects with the metabolic syndrome.

NCT ID: NCT01094158 Completed - Metabolic Syndrome Clinical Trials

Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis

Aramchol003
Start date: November 2010
Phase: Phase 2
Study type: Interventional

Primary purpose: Compare the changes in liver triglycerides concentration in the Aramchol versus the placebo arm following three month treatment. Secondary purpose: Comparing liver enzymes, markers of endothelial dysfunction, insulin resistance, SCD1 activity and cholesterol synthesis and lipid levels, between the Aramchol and the placebo arms.

NCT ID: NCT01066364 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

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

The purpose of the study is to see if the drug colesevelam is a potential treatment for Nonalcoholic Steatohepatitis(NASH).

NCT ID: NCT01051219 Completed - Clinical trials for Nonalcoholic Steatohepatitis

Anti-Fibrotic Effects of Losartan In Nash Evaluation Study

FELINE
Start date: May 2011
Phase: Phase 3
Study type: Interventional

This is a randomized, controlled trial to determine whether Losartan is effective at slowing down, halting or reversing liver fibrosis in patients with non-alcoholic steatohepatitis (NASH). Liver fibrosis is the accumulation of tough, fibrous scar tissue in the liver which occurs in patients with NASH. NASH resembles alcoholic liver disease, but occurs in people who drink little or no alcohol. The major feature in NASH is fat in the liver, along with inflammation and damage, which may lead to cirrhosis, in which the liver is permanently damaged and scarred and no longer able to function properly. Primary hypothesis: That losartan is superior to placebo in reversing, slowing down or halting fibrosis in patients with non-alcoholic fatty liver disease, after 24 months of treatment. Secondary hypothesis: 1. That the safety profile of the angiotensin receptor blocker (losartan) in this patient population is acceptable 2. That losartan can prevent clinical deterioration in non-alcoholic fatty liver disease 3. That serum, radiological and histological markers of fibrosis correlate in these patients over a 24 month period