| 1 |
NCT02669641 |
Unknown † |
Complex Imaging Assessment of Steatosis |
|
- Dietary Supplement: Combination Silimarin, Phyllanthus niruri and Choline
|
Interventional
|
Phase 4 |
- University of Medicine and Pharmacy Craiova
- Fiterman Pharma SRL
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT02669641 |
SteatoSPC
1334/17.12.2015 |
SteatoSPC |
January 2016 |
June 2016 |
December 2016 |
February 1, 2016 |
February 1, 2016 |
|
- Research Center in Gastroenterology and Hepatology, University of Medicine and Pharmacy Craiova, Romania
Craiova, Please Select, Romania
|
|
| 2 |
NCT01992809 |
Completed |
Omega 3 Supplementation in Fatty Liver |
|
- Dietary Supplement: Omega 3
|
Interventional
|
Phase 3 |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double (Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy in reduce inflammatory component of NASH for NAS score
- Inflammatory systemic profile
|
60 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01992809 |
0681/09CAPPESQ |
OMEGA 3 NASH |
September 2009 |
June 2011 |
June 2011 |
November 25, 2013 |
November 25, 2013 |
|
- University of Sao Paulo School of Medicine
Sao Paulo, Brazil
|
|
| 3 |
NCT03198572 |
Not yet recruiting |
Efficacy and Safety of Berberine in Non-alcoholic Steatohepatitis |
- Non-alcoholic Steatohepatitis
|
- Behavioral: Lifestyle intervention
- Drug: Placebo
- Drug: Berberine
|
Interventional
|
Phase 4 |
- Fudan University
- Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- (and 4 more...)
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Improvement in histologic features of nonalcoholic steatohepatitis by NAFLD activity score (NAS)
- Improvement in the composites of NAFLD activity scores for steatosis, lobular inflammation, hepatocellular ballooning
- Improvement in liver histological fibrosis staging
- (and 11 more...)
|
120 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03198572 |
2016ZSLC04 |
EASYBEinNASH |
July 2017 |
December 2019 |
July 2020 |
June 26, 2017 |
June 26, 2017 |
|
- Department of Endocrinology and Metabolism,Shanghai 6th People's Hospital
Shanghai, Shanghai, China - The Affiliated Hospital of Hangzhou Normal University
Hangzhou, China - Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China - (and 3 more...)
|
|
| 4 |
NCT02575625 |
Unknown † |
Fibroscan® Medical Device, Assessment for Non Invasive Diagnosis of Liver Steatosis |
|
- Device: Fibroscan
- Biological: Blood test for biological assessment of liver function
- Device: MRI
|
Interventional
|
Not Applicable |
- University Hospital, Tours
- Echosens
- Institut National de la Santé Et de la Recherche Médicale, France
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Viscosity in Pa.s
- Elasticity in kPa
- Reproductibility quantification in arbitrary unit
- (and 2 more...)
|
85 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02575625 |
PHAO2011-FP/TRANSTEATOSE |
TRANSTEATOSE |
April 2013 |
October 2015 |
October 2015 |
October 14, 2015 |
October 16, 2015 |
|
- University Hospital of Tours
Tours, France
|
|
| 5 |
NCT01792115 |
Active, not recruiting |
Treatment for Non-Alcoholic Fatty Liver With Different Doses of Vitamin E |
|
- Drug: Vitamin E 200 IU/d
- Drug: Vitamin E 400 IU/d
- Drug: Vitamin E 800 IU/d
- Behavioral: Diet and Exercise
|
Interventional
|
Phase 2 |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- National Institutes of Health Clinical Center (CC)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Biochemical: Percent of patients with normal transaminases at end of treatment.
- Percent and relative change in transaminases and GGT. Percent change in liver fat content.
- Changes in hepatic and adipose tissue gene expression, oxidative stress and NH/NKT cell phenotype in response to treatment.
|
38 |
All |
18 Years and older (Adult, Older Adult) |
NCT01792115 |
130002
13-DK-0002 |
|
February 13, 2013 |
August 1, 2019 |
August 1, 2019 |
February 15, 2013 |
June 13, 2018 |
|
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
|
|
| 6 |
NCT00575757 |
Completed |
Relationship of Metabolic Abnormalities to Hepatic Steatosis in HIV |
|
|
Observational
|
|
- Virginia Commonwealth University
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- What is the spectrum of NAFLD in HIV
- How does the spectrum compare in those that are on a PI compare to those that are not.
- What are the independent predictive factors associated with hepatic steatosis and NASH?
|
12 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT00575757 |
VCUHM10107
1R03DK075416-01 |
|
July 2007 |
July 2016 |
July 2016 |
December 18, 2007 |
August 18, 2016 |
|
- Virgnia Commonwealth University
Richmond, Virginia, United States
|
|
| 7 |
NCT03375008 |
Recruiting |
Predictable MR Index for Nonalcoholic Steatohepatitis (NASH) |
- Nonalcoholic Steatohepatitis
|
- Diagnostic Test: Imaging diagnostic and biopsy
|
Interventional
|
Not Applicable |
- Korea University Guro Hospital
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Radiologic Diagnosis & Criteria of nonalcoholic steatohepatitis(NASH)
- Fat imaging : Fat signal fraction measured on magnetic resonance(MR) spectroscopy
- Fibrosis imaging(1) : Liver stiffness measured on magnetic resonance elastography(MRE)
- (and 3 more...)
|
40 |
All |
19 Years and older (Adult, Older Adult) |
NCT03375008 |
KUGH16184 |
|
September 8, 2016 |
August 7, 2018 |
August 7, 2018 |
December 15, 2017 |
December 15, 2017 |
|
- Korea University Guro Hospital
Seoul, Guro-gu, Korea, Republic of
|
|
| 8 |
NCT00736385 |
Terminated
Has Results |
Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) |
|
- Drug: Glucophage (Metformin)
- Drug: Placebo
|
Interventional
|
Phase 4 |
- Manal Abdelmalek
- Duke University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Study Endpoints Will Include Measurements of Insulin Sensitivity, Hepatic Insulin Clearance, and Altered Parameters of Lipid Metabolism, Changes in the Histological Features That Define NAFLD, and Quantitative Measurements of Visceral and Peripheral Fat.
- Tests the Postulate That Metformin Will Improve Insulin Sensitivity in NAFLD. Also Test the Postulate That Improving IR (Insulin Resistance) With an Insulin Sensitizing Agent Will Improve Biochemical and Histological Features of NAFLD.
- Determine if Metformin Improves the Altered Parameters of Lipid Metabolism as Compared to Placebo.
- Measure the Differential Effects of IR and Lipid Metabolism on Peripheral Mononuclear Cell (PBMC) Inflammatory Response and the Associated Hepatocyte Mitochondrial Ultrastructure and Measures of Oxidative Stress
|
11 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00736385 |
Pro00006196
K23DK062116 |
NAFLD |
April 2009 |
December 2012 |
December 2012 |
August 15, 2008 |
December 7, 2016 |
March 26, 2015 |
- Duke University Medical Center
Durham, North Carolina, United States
|
|
| 9 |
NCT01725035 |
Completed |
Hepatic De Novo Lipogenesis (DNL)in the Pathogenesis of Hepatic Steatosis in Obese Youth |
- Hepatic Steatosis
- Fatty Liver
|
|
Observational
|
|
- Yale University
- American Heart Association
|
Other |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- de novo lipogenesis response to high carbohydrate meal in obese kids with fatty liver
- de novo lipogenesis response to high carbohydrate meal in obese kids without fatty liver
|
14 |
All |
12 Years to 18 Years (Child, Adult) |
NCT01725035 |
1008007192
11CRP5620013 |
DNL |
December 2010 |
April 2016 |
April 2016 |
November 12, 2012 |
April 7, 2016 |
|
- Yale University
New Haven, Connecticut, United States
|
|
| 10 |
NCT02009592 |
Completed |
Efficacy of Rifaximin on Hepatosteatosis and Steatohepatitis Patients |
- Fatty Liver
- Steatohepatitis
|
|
Interventional
|
Not Applicable |
- Bezmialem Vakif University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Drop in the levels of pro-inflammatory cytokines and increase in anti-inflammatory cytokines
|
42 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT02009592 |
18245212-108-99/164 |
|
June 2013 |
January 2014 |
February 2014 |
December 12, 2013 |
May 16, 2014 |
|
- Bezmialem Vakif University
Istanbul, Turkey
|
|
| 11 |
NCT03421431 |
Recruiting |
A Study to Assess the Safety, Tolerability, Pharmacokinetics and Efficacy of EDP-305 in Subjects With Non-Alcoholic Steatohepatitis |
- Non-Alcoholic Steatohepatitis
|
- Drug: EDP-305 Dose 1
- Drug: EDP-305 Dose 2
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Enanta Pharmaceuticals
- ICON Clinical Research
- Triangle Biostatistics
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Change from baseline in ALT levels at Week 12
- Safety as measured by frequency of adverse events (AEs), serious AEs, and AEs leading to discontinuation through Week 12
|
125 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03421431 |
EDP 305-101 |
|
March 2018 |
March 2019 |
April 2019 |
February 5, 2018 |
March 29, 2018 |
|
- Texas Clinical Research Institute
Arlington, Texas, United States - Texas Liver Institute
San Antonio, Texas, United States
|
|
| 12 |
NCT01617772 |
Recruiting |
Atorvastatin, L-Carnitine and Non-Alcoholic Steatohepatitis |
- Non-alcoholic Steatohepatitis
|
- Drug: Atorvastatin
- Drug: L-Carnitine
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Tehran University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- improvement in liver stiffness
- improvement in liver enzyme levels
- Adverse drug events
|
440 |
All |
40 Years to 60 Years (Adult) |
NCT01617772 |
90-03-37-15428 |
NALCAT |
January 1, 2016 |
October 2019 |
December 2019 |
June 12, 2012 |
May 11, 2018 |
|
- Pars Cohort Center
Shiraz, Fars, Iran, Islamic Republic of - Masoud Clinic
Tehran, Iran, Islamic Republic of
|
|
| 13 |
NCT03480594 |
Not yet recruiting |
Effect of Fatty Liver on TCA Cycle Flux and the Pentose Phosphate Pathway |
|
- Drug: Hyperpolarized [13C] Pyruvate Injection
|
Interventional
|
Early Phase 1 |
- University of Texas Southwestern Medical Center
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Basic Science
|
- Bicarbonate:lactate ratio
- Labeled glycerol fraction
|
16 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT03480594 |
082017-019 |
HPFFF |
May 1, 2018 |
December 31, 2020 |
December 31, 2020 |
March 29, 2018 |
March 29, 2018 |
|
|
|
| 14 |
NCT00099723 |
Terminated |
The Effect of a Probiotic on Hepatic Steatosis |
|
|
Interventional
|
Phase 1 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- MRI
- Liver biopsy
- Blood work
|
30 |
All |
45 Years to 70 Years (Adult, Older Adult) |
NCT00099723 |
SS01305-01
R21AT001305-01 |
|
October 2004 |
|
December 2005 |
December 20, 2004 |
February 11, 2010 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
|
| 15 |
NCT01100398 |
Completed |
Prevalence of Nonalcoholic Fatty Liver Disease (NAFLD) and Nonalcoholic Steatohepatitis (NASH) Utilizing Ultrasound and Percutaneous Liver Biopsy |
|
- Procedure: possible liver biopsy and serum collection
|
Observational
|
|
- Brooke Army Medical Center
|
U.S. Fed |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
400 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT01100398 |
Williams-NASH1 |
|
January 2007 |
May 2010 |
May 2010 |
April 9, 2010 |
December 24, 2010 |
|
- Brooke Army Medical Center
Fort Sam Houston, Texas, United States
|
|
| 16 |
NCT01761370 |
Completed |
Intragastric Balloon for Treatment of Non Alcoholic Steatohepatitis (NASH) |
- Non Alcoholic Steatohepatitis
|
- Procedure: AHA diet plus exercise with BIB placement
- Procedure: AHA diet plus exercise with sham BIB placement
|
Interventional
|
Not Applicable |
- National University Hospital, Singapore
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in liver histology
|
21 |
All |
21 Years to 65 Years (Adult, Older Adult) |
NCT01761370 |
D/05/338 |
|
November 2005 |
September 2008 |
September 2008 |
January 4, 2013 |
January 4, 2013 |
|
- National University Hospital
Singapore, Singapore
|
|
| 17 |
NCT00949403 |
Completed |
Liver Positron Emission Tomography (PET) Study of Non Alcoholic Fatty Liver Disease |
|
|
Observational
|
|
- Washington University School of Medicine
- Barnes-Jewish Hospital
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Hepatic Fatty Acid Oxidation
|
9 |
Female |
18 Years to 45 Years (Adult) |
NCT00949403 |
09-0621 |
Liver |
July 2010 |
January 2018 |
January 19, 2018 |
July 30, 2009 |
February 7, 2018 |
|
- Washington University School of Medicine
Saint Louis, Missouri, United States - Washington University
Saint Louis, Missouri, United States
|
|
| 18 |
NCT03542578 |
Not yet recruiting
New |
Diagnosis of Fatty Liver With Outpatient Ultrasound |
|
- Device: outpatient evaluation of fatty liver
|
Observational
|
|
- Medical College of Wisconsin
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Outpatient ultrasound in diagnosis of fatty liver diagnosis
|
500 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03542578 |
PRO00029401 |
|
June 1, 2018 |
June 30, 2023 |
June 30, 2023 |
May 31, 2018 |
May 31, 2018 |
|
|
|
| 19 |
NCT01950884 |
Unknown † |
Lifestyle Versus Ezetimibe Plus Lifestyle in Patients With Non-alcoholic Steatohepatitis |
- •Non-alcoholic Steatohepatitis (NASH)
|
- Drug: Ezetimibe
- Behavioral: Lifestyle
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- HISTOLOGICAL IMPROVEMENT IN THE SEVERITY OF NASH
- Changes in individual components of NAS score
|
45 |
All |
18 Years and older (Adult, Older Adult) |
NCT01950884 |
LISTEN
2013-003465-33 |
|
October 2013 |
October 2014 |
December 2014 |
September 26, 2013 |
September 26, 2013 |
|
- Dipartimento Biomedico di Medicina Interna e Specialistica Di.Bi.M.I.S.
Palermo, Italy
|
|
| 20 |
NCT02283710 |
Completed |
The Effect of Pentoxifylline on Liver Function Tests in Fatty Liver Disease |
|
- Drug: Pentoxifylline
- Behavioral: Lifestyle modification
|
Interventional
|
Phase 2 |
- Tehran University of Medical Sciences
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline serum alanine aminotransferase at 6 months
- Change from baseline serum aspartate aminotransferase at 6 months
|
120 |
All |
18 Years and older (Adult, Older Adult) |
NCT02283710 |
9011160012 |
|
May 2013 |
May 2014 |
May 2014 |
November 5, 2014 |
November 6, 2014 |
|
- Gastroenterology clinic, Sina Hospital
Tehran, Iran, Islamic Republic of
|
|
| 21 |
NCT01899859 |
Completed |
Phase 1 Study to Evaluate Safety of GR-MD-02 in Subjects With Non-Alcoholic Steatohepatitis (NASH) and Advanced Fibrosis |
- Non-Alcoholic Steatohepatitis (NASH)
|
- Drug: GR-MD-02
- Drug: Placebo
|
Interventional
|
Phase 1 |
- Galectin Therapeutics Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Primary objective is to characterize safety for GR-MD-02 administered intravenously to subjects w/ biopsy-proven NASH w/ advanced liver fibrosis. Specifically assessed by number of subjects experiencing TEAEs.
- A secondary objective is to characterize the first-dose PK profile of GR-MD-02. The PK profile is assessed by the AUC (area under the plasma concentration versus time curve) and Cmax (peak plasma concentration) of GR-MD-02.
- A secondary objective for the study is to characterize the PK profile and serum level accumulation of GR-MD-02 following administration of 3 subsequent weekly doses given by IV infusion beginning 28 days after the first dose.
- (and 2 more...)
|
31 |
All |
18 Years to 74 Years (Adult, Older Adult) |
NCT01899859 |
GT-020 |
|
July 2013 |
February 2015 |
February 2015 |
July 16, 2013 |
February 23, 2015 |
|
- Brooke Army Medical Ctr.
San Antonio, Texas, United States
|
|
| 22 |
NCT01423630 |
Active, not recruiting |
Supplementation of Probiotics and Fruit Fibre to Patients With Fatty Liver |
|
- Dietary Supplement: Probiotics and fruit fibre
|
Interventional
|
Not Applicable |
- Region Skane
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Improved and normalized liver status
- Changes in the gut bacterial flora
|
40 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT01423630 |
2008/517 |
|
August 2011 |
August 2018 |
August 2018 |
August 26, 2011 |
October 19, 2017 |
|
- Skåne University Hospital
Malmö, Sweden
|
|
| 23 |
NCT01466894 |
Withdrawn |
Safety and Efficacy Study of IMM 124-E (Bovine Colostrum) for Patients With Nonalcoholic Steatohepatitis |
- Nonalcoholic Steatohepatitis
|
- Biological: IMM 124-E
- Biological: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Safety outcome
- MRI liver fat quantitation
- ALT levels
- (and 3 more...)
|
0 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01466894 |
NASH-Immuron-002 |
|
December 2012 |
December 2013 |
December 2013 |
November 8, 2011 |
December 6, 2012 |
|
|
|
| 24 |
NCT02854605 |
Completed |
Evaluating the Safety, Tolerability, and Efficacy of GS-9674 in Participants With Nonalcoholic Steatohepatitis (NASH) |
- Nonalcoholic Steatohepatitis (NASH)
|
- Drug: GS-9674
- Drug: Placebo to match GS-9674
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Overall Safety of GS-9674 as Assessed By Proportion of Participants Experiencing Treatment Emergent Adverse Events (AEs)
- Overall Safety of GS-9674 as Assessed By Proportion of Participants with Laboratory Abnormalities
|
140 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02854605 |
GS-US-402-1852
2016-002496-10 |
|
October 26, 2016 |
January 9, 2018 |
January 9, 2018 |
August 3, 2016 |
January 17, 2018 |
|
- Ruane Clinical Research Group Inc.
Los Angeles, California, United States - Cedars Sinai Medical Center
Los Angeles, California, United States - Inland Empire Liver Foundation
Rialto, California, United States - (and 34 more...)
|
|
| 25 |
NCT02493153 |
Unknown † |
Hepatic Steatosis After Cholecystectomy |
|
- Procedure: Laparoscopic Cholecystectomy
|
Observational
|
|
- Sangchul Yun
- Soonchunhyang University Hospital
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Ultrasound finding of hepatic steatosis
|
82 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT02493153 |
HY-2013-N |
HSAC |
October 2013 |
July 2015 |
July 2016 |
July 9, 2015 |
November 23, 2015 |
|
|
|
| 26 |
NCT02541045 |
Recruiting |
Clinical Trial to Evaluate the Efficacy of Metadoxine as a Therapy for Patients With Non-alcoholic Steatohepatitis |
- Non-alcoholic Steatohepatitis
|
- Drug: metadoxine
- Other: placebo
|
Interventional
|
Phase 3 |
- Hospital General de Mexico
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- improvement in the degree of non-alcoholic fatty liver disease score (NAS)
- improvement in liver steatosis measured on a scale from 0 to 3
- improvement in lobular inflammation measured on a scale from 0 to 3
- (and 5 more...)
|
108 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02541045 |
DI/15/108/03/48 |
|
August 2015 |
August 2018 |
August 2018 |
September 4, 2015 |
August 16, 2016 |
|
- Hospital General de México
Mexico City, DF, Mexico
|
|
| 27 |
NCT01358409 |
Completed |
Regression of Myocardial Steatosis by Nebivolol |
- Cardiac Steatosis and Lipotoxicity
|
|
Interventional
|
Early Phase 1 |
- Lidia Szczepaniak
- Forest Laboratories
- Cedars-Sinai Medical Center
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Myocardial triglyceride content
- Cardiac function
- Regression of concentric cardiac remodeling
- (and 2 more...)
|
31 |
All |
18 Years to 59 Years (Adult) |
NCT01358409 |
MTG_Neb01 |
|
April 1, 2011 |
February 11, 2013 |
February 11, 2013 |
May 23, 2011 |
July 14, 2017 |
|
- Cedars-Sinai Medical Center
Los Angeles, California, United States
|
|
| 28 |
NCT00586911 |
Completed |
Betaine in Patients With Nonalcoholic Steatohepatitis |
- Nonalcoholic Steatohepatitis
|
- Drug: Cystadane
- Drug: Identical Placebo
|
Interventional
|
Phase 2 |
- Mayo Clinic
- University of Florida
- Orphan Medical
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- changes in degree of steatosis, necroinflammatory activity and fibrosis in liver biopsy.
- Secondary end-points will be changes in liver test results and health related quality of life.
|
26 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00586911 |
458-00 |
|
January 2003 |
June 2006 |
June 2006 |
January 7, 2008 |
April 8, 2015 |
|
- University of Florida at Gainesville
Gainesville, Florida, United States - Mayo Clinic
Rochester, Minnesota, United States
|
|
| 29 |
NCT00480922 |
Completed |
Effects of a Low Glycemic Load Diet on Fatty Liver in Children |
|
- Behavioral: Low glycemic load diet
- Behavioral: Low fat diet
|
Interventional
|
Not Applicable |
- Boston Children’s Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- percent liver fat as determined by nMR spectroscopy
- hepatic steatosis as measured by T1 weighted MRI images
- visceral fat
- (and 9 more...)
|
40 |
All |
8 Years to 17 Years (Child) |
NCT00480922 |
07-03-0092 (completed) |
DELIVER |
May 2007 |
December 2009 |
December 2009 |
May 31, 2007 |
August 26, 2011 |
|
- Children's Hospital
Boston, Massachusetts, United States
|
|
| 30 |
NCT00586885 |
Completed |
Effects of Alanine in Patients With Nonalcoholic Steatohepatitis |
- Nonalcoholic Steatohepatitis
|
|
Interventional
|
Not Applicable |
- Keith D Lindor, M.D.
- Ajinomoto USA, INC.
- Mayo Clinic
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- To assess the safety and tolerability of long-term L-alanine supplementation and the therapeutic efficacy of long-term L-alanine supplementation by evaluating liver biochemistry and histological findings.
- Determine the effect of L-alanine on gene profiles, anti-oxidant response and inflammatory response in hepatocytes. Evaluate possible correlation between therapeutic efficacy and gene profiles altered by L-alanine supplementation
|
9 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00586885 |
1753-03 |
|
February 2004 |
June 2006 |
June 2006 |
January 7, 2008 |
October 11, 2012 |
|
- Mayo Clinic
Rochester, Minnesota, United States
|
|
| 31 |
NCT00266019 |
Completed |
Weight Management in Nonalcoholic Steatohepatitis |
|
- Behavioral: Weight Management (diet, exercise, and behavior modification)
|
Interventional
|
Phase 2 |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Liver histology score (NASH-Clinical Research Network [CRN] scoring system) at 48 weeks
- Weight reduction at 48 weeks
- Insulin sensitivity at 48 weeks
- (and 3 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT00266019 |
DK67363 (completed) |
|
January 2005 |
|
December 2007 |
December 15, 2005 |
January 13, 2010 |
|
- Rhode Island Hospital
Providence, Rhode Island, United States
|
|
| 32 |
NCT00827450 |
Completed |
Effects of Coffee on Hepatic Steatosis Induced by a High Fructose Diet |
|
- Dietary Supplement: Ctl
- Dietary Supplement: High fructose diet; no coffee
- Dietary Supplement: fully torrefied, caffeine-free coffee
- (and 2 more...)
|
Interventional
|
Not Applicable |
- University of Lausanne
- Nestlé Research Center, Vers-chez-les-blanc, Switzerland
|
Other |
- Allocation: Randomized
- Intervention Model: Factorial Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- intra-hepatocellular lipid (IHCL) concentration
- fasting plasma triglycerides
- fasting net lipid oxidation
- (and 4 more...)
|
13 |
Male |
18 Years to 30 Years (Adult) |
NCT00827450 |
COLIBRI |
COLIBRI |
February 2009 |
December 2010 |
March 2011 |
January 22, 2009 |
February 24, 2012 |
|
- Centre d'investigations cliniques "cardiomet"/ CHUV
Lausanne, Switzerland
|
|
| 33 |
NCT00063635 |
Completed
Has Results |
Treatment of Nonalcoholic Fatty Liver Disease in Children (TONIC) |
|
- Drug: Metformin
- Dietary Supplement: Vitamin E
- Drug: Matching placebo
|
Interventional
|
Phase 3 |
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Number of Participants With Sustained Reduction in Alanine Aminotransferase (ALT) to Either 50% of Baseline Value or < 40 IU/L
- Change in Serum Aspartate Aminotransferase (AST)
- Change in Nonalcoholic Fatty Liver Disease (NAFLD) Score (Histologic Feature Scores Determined by Standardized Scoring of Liver Biopsies) From Baseline at 96 Weeks of Treatment
- (and 8 more...)
|
173 |
All |
8 Years to 17 Years (Child) |
NCT00063635 |
NASH - PEDIATRICS (IND) |
TONIC |
September 2005 |
September 2009 |
February 2010 |
July 3, 2003 |
September 27, 2012 |
September 27, 2012 |
- University of California, San Diego
San Diego, California, United States - University of California, San Francisco
San Francisco, California, United States - Children's National Medical Center
Washington, District of Columbia, United States - (and 7 more...)
|
|
| 34 |
NCT01066364 |
Unknown † |
Colesevelam Versus Placebo in the Treatment of Nonalcoholic Steatohepatitis |
- Nonalcoholic Steatohepatitis
|
|
Interventional
|
Phase 2 |
- University of California, San Diego
- Daiichi Sankyo, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The primary outcome will be improvement in hepatic steatosis by liver MRI
- Insulin sensitivity as determined by HOMA-IR
- Serum ALT and AST values
- Lipid profiles
|
54 |
All |
18 Years and older (Adult, Older Adult) |
NCT01066364 |
091491 |
|
February 2010 |
February 2012 |
February 2012 |
February 10, 2010 |
February 10, 2010 |
|
- UCSD: Prevention Studies Clinic
La Jolla, California, United States - UCSD: Medical Center- Hillcrest
San Diego, California, United States
|
|
| 35 |
NCT00680407 |
Completed
Has Results |
Phase II Trial of Silymarin for Non-Cirrhotic Patients With Non-Alcoholic Steatohepatitis |
- Non-alcoholic Steatohepatitis
|
- Other: Placebo
- Drug: Silymarin 700 mg
- Drug: Silymarin 420 mg
|
Interventional
|
Phase 2 |
- Madaus Inc
- University of Pennsylvania
- University of North Carolina
- (and 4 more...)
|
Industry / Other / U.S. Fed |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy - Improvement by at Least 2 Points in Histology (NAS)
- Safety - Occurrence of a Dose-limiting Toxicity
|
78 |
All |
18 Years and older (Adult, Older Adult) |
NCT00680407 |
U01AT003566-02
IND 105,461 (orig. IND 74,887) |
SyNCH |
April 2008 |
November 2012 |
November 2012 |
May 20, 2008 |
January 29, 2016 |
January 29, 2016 |
- Beth Isreal Deaconess Medical Center
Boston, Massachusetts, United States - University of North Carolina - Chapel Hill
Chapel Hill, North Carolina, United States - University of Pennsylvania
Philadelphia, Pennsylvania, United States - (and 3 more...)
|
|
| 36 |
NCT03201159 |
Withdrawn |
A Pilot, Dose Escalating Study on VLX103 in Moderate Alcoholic Steatohepatitis |
|
|
Interventional
|
Phase 1 |
- Gyongyi Szabo
- The Cleveland Clinic
- University of Texas Southwestern Medical Center
- (and 3 more...)
|
Other / NIH |
- Allocation: Non-Randomized
- Intervention Model: Sequential Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Frequencies of subjects experiencing at least one adverse event will be displayed by body system and preferred term according to MedDRA terminology
- Distribution of laboratory measures over time will be prepared
- Preliminary efficacy of VLX103 in the target patient population
- (and 2 more...)
|
0 |
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT03201159 |
H00011711
VLX103-ASH-16-01
U01AA021893 |
|
June 25, 2017 |
February 27, 2018 |
February 27, 2018 |
June 28, 2017 |
May 30, 2018 |
|
- UMass Medical School
Worcester, Massachusetts, United States
|
|
| 37 |
NCT00977730 |
Completed |
The Effect of Protandim on Non-alcoholic Steatohepatitis |
- Non-Alcoholic Steatohepatitis
|
- Dietary Supplement: Protandim
- Dietary Supplement: Placebo
|
Interventional
|
Not Applicable |
- University of Colorado, Denver
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change in NAS at study completion in the Protandim group compared to the placebo group.
|
70 |
All |
18 Years and older (Adult, Older Adult) |
NCT00977730 |
07-0848 |
NASH |
July 2008 |
July 2011 |
July 2011 |
September 16, 2009 |
February 5, 2013 |
|
- University of Colorado at Denver and Health Sciences Center
Denver, Colorado, United States
|
|
| 38 |
NCT00681408 |
Completed |
Omega 3 Fish Oil Supplements vs. Placebo for Patients With Non-alcoholic Steatohepatitis (NASH) |
- Non-alcoholic Steatohepatitis
- Fatty Liver
|
- Drug: Omega 3 Fish Oil supplements
- Drug: Placebo
|
Interventional
|
Phase 2
Phase 3 |
- University of Virginia
- National Center for Complementary and Integrative Health (NCCIH)
|
Other / NIH |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- The Primary endpoint will be improvement in a composite score of histological injury as measured by the NASH Activity Score (NAS).
- Measurement of anthropometric indices (weight, BMI, waist circumference)
- Index of cardiorespiratory fitness determined by exercise tolerance (measured by lactate threshold on an exercise treadmill)
- (and 2 more...)
|
41 |
All |
21 Years and older (Adult, Older Adult) |
NCT00681408 |
12442
R21AT002901
IRB # 12442
GCRC: SHC003
Grant # 5R21AT2901-2 |
|
March 2007 |
August 2010 |
August 2010 |
May 21, 2008 |
May 29, 2015 |
|
- University of Virginia School of Medicine
Charlottesville, Virginia, United States
|
|
| 39 |
NCT00845845 |
Terminated
Has Results |
Fish Oil and Diet for the Treatment of Non-Alcoholic Steatohepatitis (NASH) |
- Nonalcoholic Steatohepatitis (NASH)
- Hepatic Steatosis
|
- Drug: Omega-3-acid ethyl esters (Lovaza)
- Drug: Placebo
|
Interventional
|
Phase 2 |
- University of Illinois at Chicago
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Omega-3 Fatty Acid Supplementation and Its Effect on Hepatic Steatosis and Other Factors Associated With the Development of Nonalcoholic Steatohepatitis (NASH)
- Magnetic Resonance Imaging (MRI) as an Assessment of Hepatic Steatosis in Patients With Biopsy-proven Nonalcoholic Steatohepatitis (NASH)
|
12 |
All |
18 Years and older (Adult, Older Adult) |
NCT00845845 |
2003-0601 |
|
March 2006 |
October 2010 |
October 2010 |
February 18, 2009 |
July 24, 2013 |
July 24, 2013 |
- The University of Illinois Chicago
Chicago, Illinois, United States
|
|
| 40 |
NCT01056133 |
Completed |
Effect of Fish-oil on Non-alcoholic Steatohepatitis (NASH) |
- Non-alcoholic Fatty Liver Disease
- Non-alcoholic Steatohepatitis
|
- Other: Omega-3 capsules-Fish Oil
|
Interventional
|
Phase 2 |
- Johane Allard
- Canadian Institutes of Health Research (CIHR)
- American College of Gastroenterology
- University Health Network, Toronto
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Liver histology
- Plasma and RBC fatty acid composition and PC:PE ratio
- Blood biochemistry (blood sugar control, lipid profile, liver enzymes)
- (and 4 more...)
|
20 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01056133 |
08-0874-A
CIHR Grant#89705
MOP-123459 |
|
October 2009 |
January 2015 |
August 2015 |
January 26, 2010 |
May 12, 2016 |
|
- University Health Network, Toronto General Hospital
Toronto, Ontario, Canada
|
|
| 41 |
NCT01754714 |
Completed
Has Results |
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 |
- Non Alcoholic Fatty Liver Disease
|
- Drug: SAMe 1000 mg
- Drug: SAMe 1500 mg
- Drug: SAMe 2000 mg
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- 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
- (and 7 more...)
|
108 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT01754714 |
M13-397
2012-000975-18 |
EXPO |
December 2012 |
September 2014 |
September 2014 |
December 21, 2012 |
February 19, 2016 |
February 19, 2016 |
- Site Reference ID 93914
Amiens, France - Site Reference ID 93895
Angers, France - Site Reference ID 93894
Bobigny, France - (and 29 more...)
|
|
| 42 |
NCT02427087 |
Completed |
Sedentary Postmenopausal Women With Nonalcoholic Fatty Liver Disease (NAFLD) Submitted to Physical Activity |
|
- Behavioral: Continuous Aerobic Training twice
- Behavioral: Healthy Diet
|
Interventional
|
Not Applicable |
- University of Sao Paulo General Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Efficacy in reduce inflammatory component of NASH for transient elastography liver
- Inflammatory systemic profile
|
40 |
Female |
35 Years to 75 Years (Adult, Older Adult) |
NCT02427087 |
9022 |
|
January 2013 |
December 2014 |
December 2014 |
April 27, 2015 |
April 27, 2015 |
|
- University of Sao Paulo School of Medicine
Sao Paulo, Brazil
|
|
| 43 |
NCT02787304 |
Active, not recruiting |
Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH) |
- Non-Alcoholic Steatohepatitis
|
- Drug: SHP626
- Drug: Placebo
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48
- Change From Baseline to Week 48 on Liver Histology
- Change From Baseline to Week 48 on Hepatic Steatosis
- (and 5 more...)
|
197 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT02787304 |
SHP626-201
2016-000203-82 |
|
October 24, 2016 |
January 1, 2020 |
January 1, 2020 |
June 1, 2016 |
June 15, 2018 |
|
- Southern California Research Center
Coronado, California, United States - Fresno Clinical Research Center
Fresno, California, United States - Ceders-Sinai Medical Center
Los Angeles, California, United States - (and 62 more...)
|
|
| 44 |
NCT01284634 |
Completed
Has Results |
Study to Assess the Effect of Cannabidiol on Liver Fat Levels in Subjects With Fatty Liver Disease. |
|
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change From Baseline to the End of Treatment in Mean % Liver Triglyceride Levels
- Change From Baseline to the End of Treatment it Mean Serum Total Cholesterol Levels
- Change From Baseline to the End of Treatment in Mean Serum High Density Lipoprotein (HDL)-Cholesterol(C) Levels
- (and 31 more...)
|
25 |
All |
18 Years and older (Adult, Older Adult) |
NCT01284634 |
GWMD09112
2009-017080-41 |
|
February 2011 |
August 2012 |
September 2012 |
January 27, 2011 |
September 18, 2014 |
January 20, 2014 |
- Imperial College Healthcare NHS Trust, Robert Steiner MRI Unit, MRC Clinical Sciences Centre, Imperial College London, Hammersmith Hospital, Du Cane Road
London, United Kingdom - Manchester Royal Infirmary
Manchester, United Kingdom - MAC UK
Manchester, United Kingdom
|
|
| 45 |
NCT01277237 |
Completed |
The Effect Of Omega-3 Fatty Acids on Non-alcoholic Fatty Liver Disease |
- Non Alcoholic Fatty Liver Disease
|
- Drug: Omacor
- Drug: lactose tablet
|
Interventional
|
Phase 3 |
- University of Edinburgh
- NHS Lothian
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Liver appearance on ultrasound
- Liver function tests
- hepatocyte mitochondrial function
- Health-related Quality of Life
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT01277237 |
Edin2008-008275-34
2008-008275-34 |
|
September 2010 |
August 2012 |
August 2012 |
January 14, 2011 |
January 23, 2014 |
|
- Royal Infirmary of Edinburgh
Edinburgh, Lothian, United Kingdom
|
|
| 46 |
NCT02815891 |
Recruiting |
A 5-year Longitudinal Observational Study of Patients With Nonalcoholic Fatty Liver (NAFL) or Nonalcoholic Steatohepatitis (NASH) |
- Nonalcoholic Fatty Liver
- Nonalcoholic Steatohepatitis
|
|
Observational
|
|
- Target PharmaSolutions, Inc.
|
Industry |
- Observational Model: Cohort
- Time Perspective: Other
|
- Establish an understanding of the current natural history of NASH at academic and community medical centers
- Evaluate NASH treatment regimens being used in clinical practice
- Examine populations underrepresented in phase II-III clinical trials
- (and 4 more...)
|
15000 |
All |
6 Years and older (Child, Adult, Older Adult) |
NCT02815891 |
TARGET-NASH |
|
July 2016 |
July 2021 |
July 2021 |
June 28, 2016 |
February 13, 2018 |
|
- Banner University Medical Center - Phoenix Transplant Center and Advanced Liver Clinic
Phoenix, Arizona, United States - Stanford University
Palo Alto, California, United States - California Liver Research Institute
Pasadena, California, United States - (and 53 more...)
|
|
| 47 |
NCT03319199 |
Not yet recruiting |
The Effect of Combination Therapy Amino Acid L-CARNITINE and Magnesium on Fatty Liver |
- Fatty Liver, Nonalcoholic
|
- Dietary Supplement: "SLIM WATER"
- Other: Placebo - water
|
Interventional
|
Not Applicable |
- RAWI HAZZAN
- HaEmek Medical Center, Israel
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- The primary outcome is decline in serum levels of Aspartate transaminase (AST) to normal value.
- Decline in serum levels of Alanine transaminase (ALT) to normal value.
- Improvement in radiological hepatic steatosis .
- Improvement in lipid profile.
|
60 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03319199 |
0068-16-EMC |
|
October 2017 |
October 2018 |
December 2018 |
October 24, 2017 |
October 24, 2017 |
|
|
|
| 48 |
NCT02855164 |
Recruiting |
Study of Safety and Efficacy of Tropifexor (LJN452) in Patients With Non-alcoholic Steatohepatitis (NASH) |
- Non-alcoholic Steatohepatitis
|
- Drug: Tropifexor (LJN452)
- Drug: Placebo
|
Interventional
|
Phase 2 |
- Novartis Pharmaceuticals
- Novartis
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Adverse event profile of different doses of tropifexor (LJN452) in patients with NASH
- Change in Transaminase levels
- Change from baseline in % of fat in the liver assessed using MRI
- (and 12 more...)
|
345 |
All |
18 Years and older (Adult, Older Adult) |
NCT02855164 |
CLJN452A2202
2015-005215-33 |
FLIGHT-FXR |
August 1, 2016 |
September 23, 2019 |
September 23, 2019 |
August 4, 2016 |
April 18, 2018 |
|
- Novartis Investigative Site
Coronado, California, United States - Novartis Investigative Site
Los Angeles, California, United States - Novartis Investigative Site
San Diego, California, United States - (and 72 more...)
|
|
| 49 |
NCT00666016 |
Completed |
Exploratory Study to Assess the Short Term Effect on Liver Enzymes and the Safety of TRO19622 in Patients With Non-Alcoholic Steatohepatitis (NASH) |
- Non-Alcoholic Steatohepatitis (NASH)
|
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mean change in ALT as assessed by an ANCOVA with the following covariates: treatment, gender, subject and time and a non parametric test (Conover-Salsburg).
- Sustained reduction in ALT to either 50% of baseline or value < or equal to ULN. Sustained reduction serum AST and GGT.Clinical and laboratory safety.
|
35 |
All |
18 Years and older (Adult, Older Adult) |
NCT00666016 |
WN29850
TRO19622 CL E Q 1159-1 |
|
April 2008 |
February 2009 |
April 2009 |
April 24, 2008 |
November 22, 2016 |
|
- Hôpital Archet 2 - Pôle de Référence Hépatite C (Niveau -2) - 151, route Saint Antoine de Ginestière
Nice, France - Groupe Hospitalier Pitié-Salpétrière - Sce Hépato-Gastroentérologie - 47-83 Bd de l'Hôpital
Paris, France
|
|
| 50 |
NCT02176811 |
Completed |
Plasma Betatrophin Levels in Non-alcoholic Fatty Liver Disease |
- Non-alcoholic Fatty Liver Disease
|
|
Observational
|
|
- Gulhane School of Medicine
|
Other |
- Observational Model: Case Control
- Time Perspective: Cross-Sectional
|
- Plasma betatrophin levels in subjects with non-alcoholic fatty liver disease and healthy controls.
|
80 |
Male |
20 Years to 40 Years (Adult) |
NCT02176811 |
GSM-052014 |
|
June 2009 |
June 2013 |
February 2014 |
June 27, 2014 |
June 27, 2014 |
|
- Gulhane School of Medicine Department of Endocrinology and Metabolism
Ankara, Turkey
|
|
Create an RSS feed from your search for:
Download the search results for: