Study of Aramchol in Patients With Fatty Liver Disease or Nonalcoholic Steatohepatitis
NCT ID: NCT01094158
Last Updated: 2012-01-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
60 participants
INTERVENTIONAL
2010-11-30
2012-01-31
Brief Summary
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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.
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Detailed Description
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The purpose of the study is to test whether Aramchol will reduce safely and effectively liver fat concentration in patients with NAFLD and NASH.
Aramchol inhibits the liver enzyme Stearoyl Coenzyme A Desaturase (SCD). It reduces fatty acid synthesis while increasing fatty acid oxidation. It was shown to reduce liver fat in animal models with diet induced Fatty Liver. It has also marked hypocholesterolemic effects, mainly via upregulation of theABCA1 cholesterol transporter. It thus causes(incomplete) SCD inhibition while being antiatherogenic
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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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high dose
Aramchol 300 mg daily (high dose)
Aramchol
300 mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months
low dose
100 mg daily (low dose)
Aramchol
100mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months
Placebo
Placebo and two doses will be compared. The Aramchol: placebo ratio is of 2:1.
Placebo
tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast
Interventions
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Aramchol
100mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months
Aramchol
300 mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months
Placebo
tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 15% of hepatocytes showing steatosis,with Fibrosis of not more than stage 3, with at most bridging fibrosis.
Patients with a NAFLD activity score 0-2 will be considered to have NAFLD. Biopsies with an activity score of 3 or more will be considered NASH.
* Triglycerides concentration in the liver of 6% or more as measured by NMRS.
* At least two elevated serum ALT levels in the previous six months, with latest test within 2 months of trial.
* Normal or only slightly impaired synthetic liver function (serum albumin \>3.5gm%, INR 0.8-1.3)
* Male or female aged 18-75 years.
* Negative pregnancy test at study entry for females of child bearing potential.
* Females of child bearing potential practicing reliable contraception throughout the study period.
* Signature of the written informed consent
Exclusion Criteria
* Evidence of fibrosis of more than stage 3 on liver biopsy.
* Patient with liver disease due to acute or chronic hepatitis A, B,C, HIV, and all other liver diseases affecting liver function. Patients with cysts, hemangiomas, or similar abnormalities, are accepted.
* BMI \> 35 or \>130 kg body weight
* Any other concomitant, significant: metabolic, infectious, inflammatory, neoplastic, or other non-liver disease.
* Various concomitant diseases requiring chronic steroid administration.
* Use of warfarin, metformin, thiaglitazones, insulin or current steroid therapy of more than 3 days.
* Use of other investigational agents \< 30 days prior to the study.
* Pregnancy
* Daily alcohol intake \> 10gm/day.
* Patients with symptoms of significant mental illness. Inability to cooperate or communicate with the investigator, who are unlikely to comply with the study requirements, or who are unable to give informed consent.
* Performance status: WHO performance status ≥4.
18 Years
75 Years
ALL
No
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Beilinson Hospital, Petach Tikva,Israel
UNKNOWN
Meir Medical Center
OTHER
Kaplan Hospital ,Rehovot,Israel
UNKNOWN
Soroka Hospital,Beer Sheva,Israel
UNKNOWN
Hadassah Medical Organization
OTHER
Hillel Yaffe Medical Center
OTHER_GOV
Rambam Hospital, Haifa, Israel
UNKNOWN
The Lady Davis Carmel Medical Center
UNKNOWN
Holy Family Hospital, Nazareth, Israel
OTHER
Ziv Hospital
OTHER_GOV
Galmed Medical Reserch
INDUSTRY
Responsible Party
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Liver unit, Department of Gastroenterology and Hepatology, Sourasky Medical Center. Tel Aviv.
Principal Investigators
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Ran Oren, Doctor
Role: PRINCIPAL_INVESTIGATOR
Liver & Gastroenterology Department,The Tel Aviv Sourasky Medical Center
Locations
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Soroka Medical Center
Beersheba, , Israel
Hillel Yaffe Medical Center
Hadera, , Israel
Rambam
Haifa, , Israel
The Lady Davis Carmel Medical Center
Haifa, , Israel
Hadassah Ein Kerem M.C
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Holy Family HOSPITAL
Nazareth, , Israel
Belinson,Rabin Medical Center
Petah Tikva, , Israel
Kaplan M.C
Rehovot, , Israel
Safed Ziv Hospital
Safed, , Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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References
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Leikin-Frenkel A, Goldiner I, Leikin-Gobbi D, Rosenberg R, Bonen H, Litvak A, Bernheim J, Konikoff FM, Gilat T. Treatment of preestablished diet-induced fatty liver by oral fatty acid-bile acid conjugates in rodents. Eur J Gastroenterol Hepatol. 2008 Dec;20(12):1205-13. doi: 10.1097/MEG.0b013e3282fc9743.
Gilat T, Leikin-Frenkel A, Goldiner I, Juhel C, Lafont H, Gobbi D, Konikoff FM. Prevention of diet-induced fatty liver in experimental animals by the oral administration of a fatty acid bile acid conjugate (FABAC). Hepatology. 2003 Aug;38(2):436-42. doi: 10.1053/jhep.2003.50348.
Safadi R, Konikoff FM, Mahamid M, Zelber-Sagi S, Halpern M, Gilat T, Oren R; FLORA Group. The fatty acid-bile acid conjugate Aramchol reduces liver fat content in patients with nonalcoholic fatty liver disease. Clin Gastroenterol Hepatol. 2014 Dec;12(12):2085-91.e1. doi: 10.1016/j.cgh.2014.04.038. Epub 2014 May 9.
Other Identifiers
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Aramchol NAFLD Phase-II
Identifier Type: -
Identifier Source: org_study_id
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