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Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Maurizio R. Averna, University of Palermo
ClinicalTrials.gov Identifier:
NCT01950884
First received: September 19, 2013
Last updated: September 23, 2013
Last verified: September 2013
  Purpose
  • NAFLD (Non-alcoholic fatty liver disease) has become the most common cause of liver disease in Western countries (hepatic manifestation of insulin resistance);
  • NAFLD represents a cardiovascular risk factor;
  • Lifestyle modification(weight loss)is the effective medical treatment recommended for NASH (Non-alcoholic Steatohepatitis);
  • Ezetimibe could represent a novel safe treatment for NAFLD (Patel 2006. Here the investigators propose a Randomized Controlled Pilot Trial to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

Condition Intervention Phase
Non-alcoholic Steatohepatitis (NASH)
Drug: Ezetimibe
Behavioral: Lifestyle
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomised Controlled Trial of Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis

Resource links provided by NLM:


Further study details as provided by University of Palermo:

Primary Outcome Measures:
  • HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH [ Time Frame: 52 WEEKS ] [ Designated as safety issue: Yes ]
    1. either improvement in NAS by at least 2 points spread across at least 2 of the NAS components or post-treatment NAS of 3 points or less;
    2. at least 1 point improvement in the score for ballooning degeneration;
    3. no worsening of the fibrosis score.


Secondary Outcome Measures:
  • Changes in individual components of NAS score [ Time Frame: 6 weeks, 24 weeks, 52 weeks ] [ Designated as safety issue: Yes ]

    Changes in:

    1. steatosis, lobular inflammation and hepatocellular balloonin;
    2. fibrosis;
    3. serum aminotransferase levels
    4. anthropometric measures, visceral adiposity index (VAI), insulin resistence, lipid profile and liver elastometry.


Other Outcome Measures:
  • Changes in the prevalence and severity of metabolic syndrome and the cardiovascular risk profile (Framingham calculator) [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 45
Study Start Date: October 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ezetimibe
Ezetimibe tablets plus lifestyle
Drug: Ezetimibe
Ezetimibe tablets
Other Name: Ezetimibe
Behavioral: Lifestyle
lifestyle
Other Name: lifestyle
Active Comparator: lifestyle
lifestyle
Behavioral: Lifestyle
lifestyle
Other Name: lifestyle

Detailed Description:

to evaluate the addictive effect of ezetimibe on liver histology, biochemical and sonographic parameters in a small (n.40) number of NASH patients randomized for 12 months in two arms: lifestyle vs lifestyle+ezetimibe.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 1.Patients older 18 years
  • 2.Histological diagnosis of possible or definite NASH, according to Kleiner scorw, within 6 months before randomization -

Exclusion Criteria:

  • 1)Average alcohol consumption > 20 g per day in women and > 30 g per day in men
  • 2)other causes of chronic liver disease 3) History of or planned gastrointestinal bypass or any additional bariatric surgery/intervention 4)Hepatic cirrhosis with Child-Pugh score of B or C, and/or concomitant HCC 5)Recent(within 6 months) or concomitant use of agents known to cause hepatic steatosis 7)Recent(within 6 months)change in dose/regimen or first treatment with vitamin E, C, betaine, s-adenosylmethionine, ursodeoxycholate, sylimarin, fibrate, statin, pentoxyfilline, angiotensin II inhibitors, orlistat, sibutramine 8)Ongoing or recent therapy (within 6 months) with vitamin D or with medications known to affect vitamin D3 metabolism 9)Any additional condition that might interfere with optimal partecipation in the study, according to Investigators opinion; 10)Be pregnant or breastfeeding.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01950884

Locations
Italy
Dipartimento Biomedico di Medicina Interna e Specialistica Di.Bi.M.I.S.
Palermo, Italy, 90127
Sponsors and Collaborators
University of Palermo
Investigators
Principal Investigator: Maurizio Averna, Professor Università degli studi di Palermo
  More Information

Publications:

Responsible Party: Maurizio R. Averna, MD, University of Palermo
ClinicalTrials.gov Identifier: NCT01950884     History of Changes
Other Study ID Numbers: LISTEN, 2013-003465-33
Study First Received: September 19, 2013
Last Updated: September 23, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Palermo:
Non-alcoholic Steatohepatitis (NASH)

Additional relevant MeSH terms:
Fatty Liver
Digestive System Diseases
Liver Diseases
Ezetimibe
Anticholesteremic Agents
Antimetabolites
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014