EXPO: 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
Sponsor
Abbott (Industry)
Overall Status
Completed
CT.gov ID
NCT01754714
Collaborator
PPD (Industry)
108
32
4
21
3.4
0.2
Study Details
Study Description
Brief Summary
Investigation the Effects of Different Doses of SAMe in Subjects with Nonalcoholic Fatty Liver Disease and non-treated matched healthy volunteers as control group
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
108 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official 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
Study Start Date
:
Dec 1, 2012
Actual Primary Completion Date
:
Sep 1, 2014
Actual Study Completion Date
:
Sep 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1000 mg SAMe (S-adenosyl-L-methionine)
|
Drug: SAMe 1000 mg
1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
|
| Experimental: 1500 mg SAMe
|
Drug: SAMe 1500 mg
1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
|
| Experimental: 2000 mg SAMe
|
Drug: SAMe 2000 mg
2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
|
| No Intervention: No treatment
|
Outcome Measures
Primary Outcome Measures
- Methionine Elimination Half-life Measured in Blood. [0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*]
After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
Secondary Outcome Measures
- Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve. [0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*]
After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
- 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test [0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*]
parameters cumulative percentage dose of 13 carbon recovered after 30, 60, 90 minutes (cPDR30, cPDR60, cPDR 90) will be evaluated
- Hepatic Panel (Liver Laboratory Parameters) [change from baseline at 6 weeks]
Serum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT)
- Metabolic Panel (Metabolic Laboratory Parameters) [change from baseline at 6 weeks]
Fasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose.
- The Metabolic Clearance Rate Measured in the Blood. [0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*]
After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
- Methionine Volume of Distribution at Week 7 (L) [0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*]
After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
- 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test [0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*]
Peak
- 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test [0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7*]
Time to peak
- Metabolic Panel (Metabolic Laboratory Parameters) [Change from baseline at 6 weeks]
Fasting plasma insulin
- Metabolic Panel (Metabolic Laboratory Parameters) [change from baseline at 6 weeks]
glycosylated hemoglobin (HbA1c)
- Metabolic Panel (Metabolic Laboratory Parameters) [change from baseline at 6 weeks]
Adiponectin
- Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) [change from baseline at 6 weeks]
C-reactive Protein (CRP)
- Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) [change from baseline at 6 weeks]
glutathione in erythrocytes
- Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) [change from baseline at 6 weeks]
oxidative stress marker (isoprostane level)
- Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers) [change from baseline at 6 weeks]
Caspase-cleaved cytokeratin (CK 18)
- Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers) [change from baseline at 6 weeks]
Hyaluronic acid
- Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve [0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7*]
After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine.
- Hepatic Panel (Liver Laboratory Parameters) [change from baseline at 6 weeks]
ALT/AST ratio
Other Outcome Measures
- Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) [change from baseline at 6 weeks]
Cytokine profile ( Interleukin-6, IL-8, IL-10 (IL), Tumor Necrosis Factor (TNF -α), monocyte chemoattractant protein (MCP-1), and Granulocyte-colony stimulating factor (G-CSF ).
- Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers) [change from baseline at 6 weeks]
Non-invasive test for liver disease (ActiTest)/Fibrotest FibroTest® : diagnoses hepatic fibrosis ActiTest® : assesses viral necro-inflammatory activity Scores between 0 and 1, the higher the score the worse The FibroTest score is 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, Gamma-glutamyl transpeptidase (GGT), Total bilirubin, and Alanine transaminase (ALT). ALT is used in a second assessment called ActiTest that is part of FibroTest.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria
-
Subjects with non-alcoholic steatohepatitis based on histology in medical history within the last 3 years
-
Subjects in a stable metabolic condition since histology for NASH (Non-alcoholic Steatohepatitis)
Exclusion Criteria
-
Subjects with extrahepatic biliary obstruction
-
Subjects with primary sclerosing cholangitis (PSC)
-
Subjects with primary biliary cirrhosis (PBC)
-
Any form of malignancy within the past 5 years and/or basal cell carcinoma and squamous cell carcinoma of the skin within the past two years
-
History of active substance abuse (oral, inhaled or injected) within one year prior to the study
-
Subjects with renal impairment (creatinine level of >2.0 mg/dL)
-
Subjects with a known hypersensitivity to the active substance (ademetionine) or methionine or to any of the inactive ingredients
-
Subjects with known genetic defects affecting the methionine cycle and/or causing homocystinuria and/or hyperhomocysteinemia (e.g., cystathionine beta-synthase deficiency, Vitamin B12 metabolism defect)
-
Subjects on total parenteral nutrition in the year prior to screening
-
Subjects after or planned for bariatric surgery (jejunoileal bypass or gastric weight loss surgery)
-
Extrahepatic cholestasis (proven by ultrasound)
-
Subjects with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 upper limit of normal (ULN)
-
Subject with serum total bilirubin (STB) > 5 ULN
-
Subjects after liver transplantation and subjects on the waiting list for liver transplantation
-
Subjects with any of the following disease in medical history:
-
Viral hepatitis (serum positive HBcAb (hepatitis B core antibody) or Hepatitis C Virus (HCV) ribonucleic acid (RNA)
-
Evidence of autoimmune liver disease
-
Wilson's disease
-
Hemochromatosis
-
Alpha-1-antitrypsin deficiency
-
Known positivity for antibody to human immunodeficiency virus (HIV)
-
Known heart failure of New York heart Association class 3 or 4
-
Current or history of significant alcohol consumption for a period of more than three consecutive months within five years prior to screening (significant alcohol consumption is defined as > 3 U (unit)/day for men and > 2 U/day for women, on average) or binge drinking or inability to reliably quantify alcohol consumption.
-
Clinical or histological evidence of cirrhosis F4
-
Subjects with history of biliary diversion
-
Subjects with uncontrolled diabetes mellitus defined by HbA1c (hemoglobin A1c) > 8.0 % at screening
-
Concomitant medication of B12, folate, betaine or choline
-
Concomitant treatment with glitazone within the past year prior to the study
-
Subjects with known folate or B12 deficiency
-
BMI (body mass index) > 40 kg/m2
-
History of major depression diagnostic and statistical manual of mental disorders (DSM-IV) or bipolar disease
-
Women of childbearing potential: positive urine pregnancy test during screening or unwillingness to use an effective form of birth control during the study.
-
Breastfeeding women
-
Any condition that, in the opinion of the investigator, does not justify the patient's inclusion into the study
-
Investigational drug intake within one month prior to the study
-
Active, serious medical disease with likely life-expectancy less than five years
-
Uncooperative attitude or reasonable likelihood for non-compliance with the protocol or any other reason that, in the investigator's opinion, prohibits the inclusion of the subject into the study
-
Legal incapacity or limited legal capacity, or who are incarcerated.
-
Inability to return for scheduled visits.
-
Inability to understand and follow the requirements of the protocol in the local language
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Site Reference ID 93914 | Amiens | France | 80054 | |
| 2 | Site Reference ID 93895 | Angers | France | 49933 | |
| 3 | Site Reference ID 93894 | Bobigny | France | 93009 | |
| 4 | Site Reference ID 93913 | Montpellier | France | 34295 | |
| 5 | Site Reference ID 93916 | Nice | France | 06202 | |
| 6 | Site Reference ID 93915 | Paris | France | 75012 | |
| 7 | Site Reference ID 93893 | Paris | France | 75651 | |
| 8 | Site Reference ID 93896 | Pessac | France | 33604 | |
| 9 | Site Reference ID 93953 | Bonn | Germany | 53127 | |
| 10 | Site Reference ID 93954 | Frankfurt | Germany | 60594 | |
| 11 | Site Reference ID 93935 | Freiburg | Germany | 79106 | |
| 12 | Site Reference ID 93955 | Halle | Germany | 06120 | |
| 13 | Site Reference ID 93917 | Hannover | Germany | 30625 | |
| 14 | Site Reference ID 93933 | Homburg | Germany | 66424 | |
| 15 | Site Reference ID 94015 | Leipzig | Germany | 04103 | |
| 16 | Site Reference ID 93918 | Mainz | Germany | 55131 | |
| 17 | Site Reference ID 94014 | Ulm | Germany | 89081 | |
| 18 | Site reference ID/Investigator # 109455 | Bydgoszcz | Poland | 85-030 | |
| 19 | Site Reference ID 93958 | Chorzow | Poland | 41-500 | |
| 20 | Site Reference ID 93973 | Krakow | Poland | 31-531 | |
| 21 | Site Reference ID 93956 | Lodz | Poland | 91-347 | |
| 22 | Site Reference ID 93957 | Myslowice | Poland | 41-400 | |
| 23 | Site Reference ID 93974 | Warsaw | Poland | 02-507 | |
| 24 | Site Reference ID 93975 | Wroclaw | Poland | 50-220 | |
| 25 | Site reference ID ORG-000905 | Krasnoyarsk | Russian Federation | 660022 | |
| 26 | Site reference ID ORG-000906 | Moscow | Russian Federation | 119435 | |
| 27 | Site reference ID ORG-000900 | Nizhniy Novgorod | Russian Federation | 603126 | |
| 28 | Site reference ID ORG-000907 | Novosibirsk | Russian Federation | 630084 | |
| 29 | Site reference ID ORG-000903 | Omsk | Russian Federation | 644043 | |
| 30 | Site reference ID ORG-000920 | Rostov-on-Don | Russian Federation | 344022 | |
| 31 | Site reference ID ORG-000904 | Samara | Russian Federation | 443011 | |
| 32 | Site reference ID ORG-000901 | Stavropol | Russian Federation | 355017 |
Sponsors and Collaborators
- Abbott
- PPD
Investigators
- Study Director: Suntje Sander-Struckmeier, PhD, Abbott
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Abbott
ClinicalTrials.gov Identifier:
NCT01754714
Other Study ID Numbers:
- M13-397
- 2012-000975-18
First Posted:
Dec 21, 2012
Last Update Posted:
Feb 19, 2016
Last Verified:
Jan 1, 2016
Keywords provided by Abbott
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Period Title: Overall Study | ||||
| STARTED | 27 | 27 | 26 | 28 |
| COMPLETED | 27 | 26 | 24 | 27 |
| NOT COMPLETED | 0 | 1 | 2 | 1 |
Baseline Characteristics
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment | Total |
|---|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | no study drug was administered | Total of all reporting groups |
| Overall Participants | 27 | 27 | 26 | 28 | 108 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
23
85.2%
|
24
88.9%
|
23
88.5%
|
21
75%
|
91
84.3%
|
| >=65 years |
4
14.8%
|
3
11.1%
|
3
11.5%
|
7
25%
|
17
15.7%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
51.2
(13.8)
|
50.0
(12.3)
|
49.5
(14.2)
|
56.6
(11.6)
|
51.9
(13.1)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
15
55.6%
|
10
37%
|
9
34.6%
|
11
39.3%
|
45
41.7%
|
| Male |
12
44.4%
|
17
63%
|
17
65.4%
|
17
60.7%
|
63
58.3%
|
| Region of Enrollment (participants) [Number] | |||||
| Russian Federation |
5
18.5%
|
6
22.2%
|
5
19.2%
|
2
7.1%
|
18
16.7%
|
| Poland |
3
11.1%
|
2
7.4%
|
6
23.1%
|
6
21.4%
|
17
15.7%
|
| France |
6
22.2%
|
5
18.5%
|
4
15.4%
|
9
32.1%
|
24
22.2%
|
| Germany |
13
48.1%
|
14
51.9%
|
11
42.3%
|
11
39.3%
|
49
45.4%
|
Outcome Measures
| Title | Methionine Elimination Half-life Measured in Blood. |
|---|---|
| Description | After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine. |
| Time Frame | 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [hour] |
4.29
(1.86)
|
4.66
(1.57)
|
4.25
(1.64)
|
4.26
(1.44)
|
| Title | Fasting Methionine Concentration of Average Methionine Concentration Versus Time Curve. |
|---|---|
| Description | After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine. |
| Time Frame | 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [mcg/mL] |
4.02
(0.92)
|
3.81
(0.67)
|
5.68
(10.13)
|
5.62
(8.53)
|
| Title | 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test |
|---|---|
| Description | parameters cumulative percentage dose of 13 carbon recovered after 30, 60, 90 minutes (cPDR30, cPDR60, cPDR 90) will be evaluated |
| Time Frame | 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| 13C methionine breath test recovery at 30 min (%) |
0.93
(0.73)
|
0.77
(0.51)
|
0.88
(0.66)
|
0.69
(0.55)
|
| 13C methionine breath test recovery at 60 min (%) |
3.66
(1.99)
|
3.49
(1.74)
|
3.61
(1.78)
|
2.98
(1.72)
|
| 13C methionine breath test recovery at 90 min (%) |
6.69
(2.75)
|
6.60
(2.56)
|
6.68
(2.48)
|
5.74
(2.56)
|
| Title | Hepatic Panel (Liver Laboratory Parameters) |
|---|---|
| Description | Serum Total Bilirubin (STB), Serum Conjugated Bilirubin (SCB), liver-alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), Gamma Glutamyl Transpeptidase (GGT) |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| ALP |
1.9
(7.9)
|
-0.1
(13.7)
|
3.4
(24.1)
|
-6.0
(16.9)
|
| ALT |
-6.2
(19.5)
|
-6.3
(23.5)
|
-4.9
(32.2)
|
-11.9
(33.4)
|
| AST |
-5.1
(15.7)
|
-3.0
(16.5)
|
-1.2
(10.7)
|
-11.6
(27.7)
|
| GGT |
-1.1
(33.7)
|
-10.6
(62.7)
|
-2.7
(35.7)
|
-12.3
(48.1)
|
| Title | Metabolic Panel (Metabolic Laboratory Parameters) |
|---|---|
| Description | Fasting lipid profile (cholesterol, HDL (High Density Lipoprotein), LDL (Low Density Lipoprotein)), amino acid profile, homeostasis model assessment (HOMA-R) and fasting glucose. |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Cholesterol |
-0.131
(0.593)
|
0.046
(0.921)
|
-0.265
(0.601)
|
-0.134
(0.659)
|
| HDL |
-0.094
(0.166)
|
-0.046
(0.254)
|
-0.098
(0.169)
|
-0.075
(0.188)
|
| LDL |
0.125
(0.452)
|
0.182
(0.762)
|
-0.202
(0.589)
|
-0.112
(0.558)
|
| HOMA-R |
0.837
(13.232)
|
0.127
(3.763)
|
-1.549
(13.321)
|
3.432
(10.837)
|
| Glucose |
-0.068
(0.968)
|
0.490
(1.486)
|
-0.163
(1.009)
|
-0.121
(1.610)
|
| Title | Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) |
|---|---|
| Description | Cytokine profile ( Interleukin-6, IL-8, IL-10 (IL), Tumor Necrosis Factor (TNF -α), monocyte chemoattractant protein (MCP-1), and Granulocyte-colony stimulating factor (G-CSF ). |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| IL-6: n= (27,24,23,27) |
0.0603
(2.0263)
|
-0.9254
(6.4599)
|
-1.3194
(4.5779)
|
0.1597
(1.6243)
|
| IL-8: n= (8,6,7,9) |
-14.41
(41.07)
|
0.65
(13.37)
|
-78.73
(187.51)
|
-6.17
(16.94)
|
| IL-10: n= (1,2,1,2) |
0.270
(NA)
|
-0.045
(0.106)
|
-0.300
(NA)
|
1.600
(1.146)
|
| TNF-alpha: n= (24,24,20,27) |
-0.127
(0.414)
|
-1.083
(4.782)
|
-0.601
(2.136)
|
-0.187
(1.114)
|
| MCP-1: n= (27,25,24,27) |
-29.75
(154.75)
|
-20.60
(79.71)
|
-40.15
(96.21)
|
-44.51
(114.85)
|
| G-CSF: n= (5,4,1,0) |
-20.0
(52.8)
|
-0.5
(9.7)
|
20.0
(NA)
|
NA
(NA)
|
| Title | Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers) |
|---|---|
| Description | Non-invasive test for liver disease (ActiTest)/Fibrotest FibroTest® : diagnoses hepatic fibrosis ActiTest® : assesses viral necro-inflammatory activity Scores between 0 and 1, the higher the score the worse The FibroTest score is 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, Gamma-glutamyl transpeptidase (GGT), Total bilirubin, and Alanine transaminase (ALT). ALT is used in a second assessment called ActiTest that is part of FibroTest. |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| ActiTest Score |
-0.017
(0.098)
|
-0.022
(0.137)
|
-0.002
(0.168)
|
-0.042
(0.096)
|
| Fibrotest Score |
0.036
(0.097)
|
0.028
(0.093)
|
0.050
(0.125)
|
0.020
(0.068)
|
| Title | The Metabolic Clearance Rate Measured in the Blood. |
|---|---|
| Description | After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine. |
| Time Frame | 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [L/h] |
8.86
(2.93)
|
9.83
(3.27)
|
10.05
(4.32)
|
8.23
(2.30)
|
| Title | Methionine Volume of Distribution at Week 7 (L) |
|---|---|
| Description | After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine. |
| Time Frame | 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [L] |
54.40
(18.43)
|
62.84
(14.04)
|
64.58
(17.77)
|
8.23
(53.98)
|
| Title | 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test |
|---|---|
| Description | Peak |
| Time Frame | 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [Atom %C13] |
1.0972
(0.0062)
|
1.0964
(0.0052)
|
1.0964
(0.0053)
|
1.0949
(0.0045)
|
| Title | 13 Carbon (Natural, Stable Isotope of Carbon) Methionine Breath Test |
|---|---|
| Description | Time to peak |
| Time Frame | 0.5, 1, 1.5, 3, 4.5, 6, 7.5 and 9 hours*at Week 7* |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Median (Inter-Quartile Range) [minutes] |
70.0
|
70.0
|
70.0
|
70.0
|
| Title | Metabolic Panel (Metabolic Laboratory Parameters) |
|---|---|
| Description | Fasting plasma insulin |
| Time Frame | Change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [pmol/L] |
0.3
(191.0)
|
-13.6
(115.5)
|
-13.1
(248)
|
69.1
(309.0)
|
| Title | Metabolic Panel (Metabolic Laboratory Parameters) |
|---|---|
| Description | glycosylated hemoglobin (HbA1c) |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [Percentage] |
-0.08
(0.28)
|
-0.06
(0.36)
|
-0.05
(0.32)
|
0.02
(0.33)
|
| Title | Metabolic Panel (Metabolic Laboratory Parameters) |
|---|---|
| Description | Adiponectin |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [mcg/mL] |
0.754
(4.191)
|
0.425
(1.199)
|
0.219
(1.661)
|
0.045
(1.515)
|
| Title | Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) |
|---|---|
| Description | C-reactive Protein (CRP) |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [nmol/L] |
-0.79
(15.51)
|
-0.80
(14.90)
|
-8.02
(20.40)
|
-4.80
(12.8)
|
| Title | Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) |
|---|---|
| Description | glutathione in erythrocytes |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [mcmol/g] |
-0.24
(2.06)
|
-0.21
(1.01)
|
0.05
(1.41)
|
-0.30
(1.33)
|
| Title | Immunological/Anti-oxidant Panel (Immunological and Anti-oxidant Laboratory Parameters) |
|---|---|
| Description | oxidative stress marker (isoprostane level) |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [ng/mg Crea] |
-0.223
(0.801)
|
0.116
(0.699)
|
0.290
(0.691)
|
-0.223
(0.641)
|
| Title | Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers) |
|---|---|
| Description | Caspase-cleaved cytokeratin (CK 18) |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [U/L] |
-126.8
(401.1)
|
-136.6
(257.3)
|
-47.0
(157.3)
|
-143.2
(532.5)
|
| Title | Fibrosis and Apoptosis Markers (Fibrosis and Apoptosis Laboratory Markers) |
|---|---|
| Description | Hyaluronic acid |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [ng/mL] |
4.67
(48.52)
|
2.03
(32.26)
|
9.40
(59.63)
|
3.02
(46.56)
|
| Title | Area Under Curve (AUC) of Average Methionine Concentration Versus Time Curve |
|---|---|
| Description | After the methionine load, blood samples will be obtained at 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours. Plasma will be analyzed for methionine. |
| Time Frame | 0.5, 1, 1.5, 3, 4, 5, 6, 7.5 and 9 hours *at Week 7* |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [mcg/mL] |
440.09
(149.96)
|
399.30
(148.90)
|
425.24
(231.88)
|
460.57
(135.63)
|
| Title | Hepatic Panel (Liver Laboratory Parameters) |
|---|---|
| Description | ALT/AST ratio |
| Time Frame | change from baseline at 6 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment |
|---|---|---|---|---|
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered |
| Measure Participants | 27 | 26 | 24 | 27 |
| Mean (Standard Deviation) [Ratio] |
-0.02
(0.23)
|
0.01
(0.21)
|
0.03
(0.18)
|
-0.01
(0.27)
|
Adverse Events
| Time Frame | ||||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment | ||||
| Arm/Group Description | SAMe 1000 mg: 1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner | SAMe 1500 mg: 1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner | SAMe 2000 mg: 2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner | No study drug was administered | ||||
All Cause Mortality |
||||||||
| 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
| 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/27 (0%) | 0/27 (0%) | 0/24 (0%) | 1/28 (3.6%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| head injury and neck injury before start of treatment | 0/27 (0%) | 0 | 0/27 (0%) | 0 | 0/24 (0%) | 0 | 1/28 (3.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||||
| 1000 mg SAMe (S-adenosyl-L-methionine) | 1500 mg SAMe | 2000 mg SAMe | No Treatment | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/27 (25.9%) | 4/27 (14.8%) | 7/24 (29.2%) | 2/28 (7.1%) | ||||
| Gastrointestinal disorders | ||||||||
| DIARRHOEA | 3/27 (11.1%) | 3 | 2/27 (7.4%) | 2 | 4/24 (16.7%) | 4 | 0/28 (0%) | 0 |
| Abdominal Pain | 0/27 (0%) | 0 | 1/27 (3.7%) | 1 | 3/24 (12.5%) | 3 | 2/28 (7.1%) | 2 |
| General disorders | ||||||||
| Fatigue | 2/27 (7.4%) | 2 | 0/27 (0%) | 0 | 0/24 (0%) | 0 | 0/28 (0%) | 0 |
| Nervous system disorders | ||||||||
| Headache | 2/27 (7.4%) | 2 | 1/27 (3.7%) | 1 | 1/24 (4.2%) | 1 | 0/28 (0%) | 0 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Associate Director Clinical Services |
|---|---|
| Organization | Abbott |
| Phone | +31 29-44-79-196 |
| taco.baardman@abbott.com |
Responsible Party:
Abbott
ClinicalTrials.gov Identifier:
NCT01754714
Other Study ID Numbers:
- M13-397
- 2012-000975-18
First Posted:
Dec 21, 2012
Last Update Posted:
Feb 19, 2016
Last Verified:
Jan 1, 2016