| Trial ID: | L0654 |
| Source ID: | EUCTR2012-000975-18-DE
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| Associated Drug: |
SAMe
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| Title: |
Open-label, Randomized, Parallel-Group, Exploratory Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects with Nonalcoholic Steatohepatitis (NASH) and non-treated matched healthy volunteers as control group
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| Acronym: |
--
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| Status: |
Not Recruiting
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| Study Results: |
No Results Available
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| Results: |
--
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| Conditions: |
Nonalcoholic Steatohepatitis <br>MedDRA version: 17.0
Level: PT
Classification code 10053219
Term: Non-alcoholic steatohepatitis
System Organ Class: 10019805 - Hepatobiliary disorders
;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
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| Interventions: |
<br>Trade Name: TRANSMETIL <br>Product Name: TRANSMETIL 500 mg <br>Pharmaceutical Form: Gastro-resistant tablet<br>INN or Proposed INN: Ademetionine 1,4-butanedisulfonate<br>CAS Number: [29908-03-0]<br>Other descriptive name: Ademetionine SD4, SAMe SD4, A
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| Outcome Measures: |
Main Objective: NASH subjects<br>The primary objective of this study is to explore the effects of different doses of SAMe on the liver using the methionine tolerance test. The primary efficacy parameter will be the methionine elimination half-life measured in blood.<br><br>Healthy volunteers<br>Primary Objective:<br>The healthy volunteer group will serve as control group to establish the reference values for the methionine tolerance test.;Secondary Objective: To explore:<br>?€? The effect of different doses of SAMe using the methionine tolerance test and 13C-methionine breath test<br>?€? Different doses of SAMe on:<br>? Hepatic panel: serum total bilirubin, serum conjugated bilirubin, alanine aminotransferase, alkaline phosphatase, total bile acids, aspartate aminotransferase, GGT, ALT/AST ratio <br>? Metabolic panel: fasting lipid profile, amino acid profile, homeostasis model assessment, fasting plasma insulin, fasting glucose, glycosylated hemoglobin and adiponectin<br>? Immunological/antioxidant panel <br>? fibrosis /apoptosis panel: caspase-cleaved cytokeratin 18, hyaluronic acid, ActiTest/Fibrotest: score calculated from the results of a six-parameter blood test, combining six serum markers with the age and gender of the patient: alpha-2- macroglobulin, haptoglobin, apolipoprotein A1, GGT, STB and ALT. <br>?€? The efficacy of different doses of SAMe on clinical global impression <br>?€? The efficacy of different doses of SAMe on EQ5/D<br>;Primary end point(s): Methionine tolerance test:<br>The primary efficacy parameter of the methionine tolerance test will be the methionine eliminiation half-life measured in blood.;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment.Secondary end point(s): Methionine tolerance test:
<br>The secondary efficacy parameter of this test will be the fasting methionine concentration and AUC of average methionine concentration versus time curve, the metabolic clearance rate and volume of distribution measured in blood.
<br>13C Methionine breath test:
<br>An additional secondary efficacy parameter will be the methionine breath test that will determine the effect of different doses of SAMe on the liver. The parameters cPDR30, cPDR60, cPDR 90, peak and time to peak will be evaluated. The breath test will be performed one day after the methionine loading test at the start and at the end of trial. Breath test parameter will be measured by the non-continuous breath test device.
<br>;Timepoint(s) of evaluation of this end point: After 6 weeks of treatment.
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| Sponsor/Collaborators: |
Abbott Laboratories GmbH
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| Gender: |
All
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| Age: |
nannan
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| Phases: |
Not applicable
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| Enrollment: |
135
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| Study Type: |
Interventional clinical trial of medicinal product
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| Study Designs: |
Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: No-treatment arm
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| Start Date: |
03/07/2012
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| Completion Date: |
--
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| Results First Posted: |
--
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| Last Update Posted: |
27 October 2014
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| Locations: |
Germany
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| URL: |
https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000975-18
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