| Trial ID: | L0453 |
| Source ID: | EUCTR2019-002073-56-FR
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| Associated Drug: |
Aramchol
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| Title: |
A Phase 3/4, Multinational, Multicenter, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of Aramchol in Subjects with Nonalcoholic Steatohepatitis (NASH)
The ARMOR Study
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| Acronym: |
--
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| Status: |
Authorised
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Nonalcoholic Steatohepatitis (NASH) <br>
MedDRA version: 22.0
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatob
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| Interventions: |
<br> Product Name: Aramchol<br> Pharmaceutical Form: Tablet<br> INN or Proposed INN: Not available<br> CAS Number: 246529-22-6<br> Other descriptive name: Aramchol (Arachidyl amido
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| Outcome Measures: |
<br> Primary end point(s): 1. Histology-Based: The Histology-Based primary endpoint will be derived from the week 52 biopsy of the initial 1200 subjects as compared to baseline biopsy and will use:<br> - Resolution of NASH defined as the Proportion (%) of subjects with resolution of NASH (defined by Ballooning of 0 and inflammation 0-1) and no worsening of liver fibrosis on NASH CRN fibrosis score (= 1 stage increase).<br> OR<br> - Improvement in Fibrosis defined as the Proportion (%) of subjects with improvement in liver fibrosis greater than or equal to one stage (NASH CRN fibrosis score) and no worsening of steatohepatitis (defined as no increase in NAS for ballooning, inflammation or steatosis)<br> 2. Clinically-Based: The Clinically-Based primary endpoint is the Proportion (%) of subjects experiencing at least 1 of the following events:<br> - All-cause mortality<br> - Liver transplant<br> - Histological progression to cirrhosis<br> - MELD score >15<br> - Hospitalization due to hepatic decompensation event(s) including:<br> -Hepatic encephalopathy grade =2 (as assessed by West Haven <br> scale)<br> -Variceal bleeding<br> -New onset ascites requiring treatment<br> -Spontaneous bacterial peritonitis as assessed by either positive <br> cell culture or cell count<br> Events will be adjudicated by an external adjudication committee.<br> ;Main Objective: To evaluate the efficacy and safety of twice daily administration (BID) of Aramchol 300mg as compared to placebo in subjects with NASH and liver fibrosis.;Secondary Objective: None;<br> Timepoint(s) of evaluation of this end point: 1) Histology based endpoint: after the initial 1200 subjects have passed the week 52 biopsy<br> 2) Clinical based endpoint: at End of Study (EoS) i.e. the time when a total of 505 pre-specified clinical events have been observed or at 5 years from last subject randomization, whichever comes first. <br> <br> Secondary end point(s): 1. At the time of the Histology-Based analysis, the Week 52 Proportion (%) of subjects with improvement in liver fibrosis greater than or equal to two stages and no worsening of NASH (defined as no increase in NAS for ballooning, inflammation, or steatosis).
<br> 2. At the time of the Histology-Based analysis, the Week 52 Proportion (%) of subjects with both Resolution of NASH and Improvement in Fibrosis.
<br> 3. At the time of the Histology-Based analysis, the Week 52 Proportion (%) of subjects with resolution of fibrosis (defined as fibrosis stage 0).
<br> 4. At EoS, Improvement in Fibrosis for the entire study population.<br> ;<br> Timepoint(s) of evaluation of this end point: 1) Histology based endpoint: after the initial 1200 subjects have passed the week 52 biopsy
<br> 2) Clinical based endpoint: at End of Study (EoS) i.e. the time when a total of 505 pre-specified clinical events have been observed or at 5 years from last subject randomization, whichever comes first.<br>
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| Sponsor/Collaborators: |
Galmed Research and Development, Ltd.
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Phase 4
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| Enrollment: |
2000
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
<br> Controlled: yes<br> Randomised: yes<br> Open: no<br> Single blind: no<br> Double blind: yes<br> Parallel group: yes<br> Cross over: no<br>
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| Start Date: |
20/09/2019
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
1 February 2020
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| Locations: |
United States;Spain;Turkey;Chile;Switzerland;United Kingdom;Italy;France;Mexico;Canada;Belgium;Brazil;Australia;Germany;Korea, Republic of
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2019-002073-56
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