Advertisement

Topics

Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis

2014-07-24 14:10:01 | BioPortfolio

Summary

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

Description

We plan to investigate the role of colesevelam, a bile-acid binding resin, in patients with NASH residing in the United States and assess liver fat changes during therapy using MRI of the liver. It can be hypothesized that colesevelam would lead to a greater improvement in insulin sensitivity and lipid profile compared with placebo and may lead to greater improvement in liver fat by MRI as compared to placebo.

In this pilot study, we propose to randomize approximately 55 patients (1:1 ratio) to either colesevelam or placebo and treat them for 24-weeks to evaluate changes in baseline insulin sensitivity, serum biochemistry (ALT and AST), and liver fat by MRI during therapy. Liver histologic changes would also be examined as an exploratory outcome for future studies.

Study Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Nonalcoholic Steatohepatitis

Intervention

Colesevelam Hcl

Location

UCSD: Prevention Studies Clinic
La Jolla
California
United States
92093

Status

Enrolling by invitation

Source

University of California, San Diego

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:10:01-0400

Clinical Trials [124 Associated Clinical Trials listed on BioPortfolio]

Safety and Efficacy of Solithromycin in the Treatment of Nonalcoholic Steatohepatitis Without Cirrhosis

The purpose of this study is to evaluate the effects of solithromycin on hepatic histology and biomarkers in patients with nonalcoholic steatohepatitis.

A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes

The purpose of this study is to assess the effect of TEV-45478, as compared with placebo, on liver health and liver fat content in patients with T2DM who also have Nonalcoholic Steatohepat...

Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

The current pilot study assesses the use of MRI to quantify hepatic steatosis. It will provide preliminary data regarding the use of omega-3 fatty acid supplementation for the treatment of...

Efficacy and Safety of Diamel in Patients With Nonalcoholic Steatohepatitis

The purpose of the study is to evaluate whether the addition of Diamel, a nutritional supplement, to hypocaloric diet and exercise could improve the histological results (steatosis, necro-...

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.Cur...

PubMed Articles [241 Associated PubMed Articles listed on BioPortfolio]

Effect of Nonalcoholic Steatohepatitis on Renal Filtration and Secretion of Adefovir.

Adefovir, an acyclic nucleotide reverse transcriptase inhibitor used to treat hepatitis B viral infection, is primarily eliminated renally through cooperation of glomerular filtration with active tubu...

Nonalcoholic steatohepatitis and hepatocellular carcinoma: Brazilian survey.

The majority of cases of hepatocellular carcinoma have been reported in individuals with cirrhosis due to chronic viral hepatitis and alcoholism, but recently, the prevalence has become increasingly r...

Emerging and future therapies for nonalcoholic steatohepatitis in adults.

Nonalcoholic steatohepatitis (NASH) is a disease of increasing prevalence with morbidity and mortality closely related to cardiovascular disease, malignancies and cirrhosis. Despite the need for pharm...

Is Western Diet-Induced Nonalcoholic Steatohepatitis in Ldlr-/- Mice Reversible?

Nonalcoholic fatty liver disease (NAFLD) is a major public health burden in western societies. The progressive form of NAFLD, nonalcoholic steatohepatitis (NASH), is characterized by hepatosteatosis, ...

A preclinical mouse model of nonalcoholic steatohepatitis and hepatocellular cancer that mimics human disease.

The lack of a preclinical model of progressive nonalcoholic steatohepatitis (NASH) that recapitulates human disease is a barrier to therapeutic development.

Medical and Biotech [MESH] Definitions

None available.

More From BioPortfolio on "Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis"

Quick Search
Advertisement
 

Relevant Topics

Drug Discovery
Clinical Approvals Clinical Trials Drug Approvals Drug Delivery Drug Discovery Generics Drugs Prescription Drugs In the fields of medicine, biotechnology and pharmacology, drug discovery is the process by which drugs are dis...

Hepatology
Hepatology is the study of liver, gallbladder, biliary tree, and pancreas, and diseases associated with them. This includes viral hepatitis, alcohol damage, cirrhosis and cancer. As modern lifestyles change, with alcoholism and cancer becoming more promi...


Searches Linking to this Trial