Clinical Trial Details

Trial ID: L0058
Source ID: NCT01754714
Associated Drug: SAMe
Title: Study to Investigate the Effects of Different Doses of S-adenosyl-L-methionine (SAMe) in Subjects With Nonalcoholic Fatty Liver Disease and Non-treated Matched Healthy Volunteers as Control Group
Acronym: EXPO
Status: Completed
Study Results: Has Results
Results: https://ClinicalTrials.gov/show/NCT01754714/results
Conditions: Non Alcoholic Fatty Liver Disease
Interventions: Drug: SAMe 1000 mg|Drug: SAMe 1500 mg|Drug: SAMe 2000 mg
Outcome Measures: Methionine Elimination Half-life Measured in Blood.|Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve.|13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test|Hepatic Panel (Liver Laboratory Parameters)|Metabolic Panel (Metabolic Laboratory Parameters)|The Metabolic Clearance Rate Measured in the Blood.|Methionine Volume of Distribution at Week 7 (L)|Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters)|Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers)|Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve
Sponsor/Collaborators: Abbott|PPD
Gender: All
Age: 18 Years to 99 Years ?? (Adult, Older Adult)
Phases: Phase 3
Enrollment: 108
Study Type: Interventional
Study Designs: Allocation: Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
Start Date: December 2012
Completion Date: September 2014
Results First Posted: February 19, 2016
Last Update Posted: February 19, 2016
Locations: Site Reference ID 93914, Amiens, France|Site Reference ID 93895, Angers, France|Site Reference ID 93894, Bobigny, France|Site Reference ID 93913, Montpellier, France|Site Reference ID 93916, Nice, France|Site Reference ID 93915, Paris, France|Site Reference ID 93893, Paris, France|Site Reference ID 93896, Pessac, France|Site Reference ID 93953, Bonn, Germany|Site Reference ID 93954, Frankfurt, Germany|Site Reference ID 93935, Freiburg, Germany|Site Reference ID 93955, Halle, Germany|Site Reference ID 93917, Hannover, Germany|Site Reference ID 93933, Homburg, Germany|Site Reference ID 94015, Leipzig, Germany|Site Reference ID 93918, Mainz, Germany|Site Reference ID 94014, Ulm, Germany|Site reference ID/Investigator # 109455, Bydgoszcz, Poland|Site Reference ID 93958, Chorzow, Poland|Site Reference ID 93973, Krakow, Poland|Site Reference ID 93956, Lodz, Poland|Site Reference ID 93957, Myslowice, Poland|Site Reference ID 93974, Warsaw, Poland|Site Reference ID 93975, Wroclaw, Poland|Site reference ID ORG-000905, Krasnoyarsk, Russian Federation|Site reference ID ORG-000906, Moscow, Russian Federation|Site reference ID ORG-000900, Nizhniy Novgorod, Russian Federation|Site reference ID ORG-000907, Novosibirsk, Russian Federation|Site reference ID ORG-000903, Omsk, Russian Federation|Site reference ID ORG-000920, Rostov-on-Don, Russian Federation|Site reference ID ORG-000904, Samara, Russian Federation|Site reference ID ORG-000901, Stavropol, Russian Federation
URL: https://ClinicalTrials.gov/show/NCT01754714

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D316 S-adenosyl-L-methionine Chemical drug DB00118 GNMT cofactor Antiviral Under clinical trials Details
D094 Cysteamine Chemical drug DB00847 GSS stimulant Renal drug Under clinical trials Details
D095 Cysteamine bitartrate Chemical drug DB00847 -- -- Under clinical trials Details