Nonalcoholic Steatohepatitis Clinical Trial
Official title:
Non-invasive Evaluation of Liver Fibrosis, Steatosis, and Nonalcoholic Steatohepatitis in Biopsy-Proven NAFLD Patients
1. To evaluate hepatic fibrosis and steatosis using MR imaging, transient elastography
(TE), and serum biomarker
2. To develop non-invasive diagnosis marker for NASH and advanced fibrosis
Status | Recruiting |
Enrollment | 150 |
Est. completion date | August 31, 2019 |
Est. primary completion date | August 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 19 Years and older |
Eligibility |
Inclusion Criteria: - Patients >19 years age - Patients who had elevated aspartate transaminase(AST)/alanine transaminase(ALT) or fatty liver on abdominal ultrasonography - Patients who are clinically suspected to have nonalcoholic steatohepatitis(NASH): >40 years age, BMI >25, multiple features of the metabolic syndrome, presence of diabetes mellitus (DM) , fibroscan > 6 kilopascal (kPa), platelet count < 150,000 /ml, and other patients suspected to progress clinically or requiring diagnosis - Patients who underwent (<6 months) or will undergo US-guided liver biopsy Exclusion Criteria: - Chronic liver disease other than nonalcoholic fatty liver disease(NAFLD) (chronic hepatitis B or C, autoimmune hepatitis, primary biliary cholangitis) - Excessive alcohol consumption (weekly men >140g and women >70g) - Fatty liver due to medication - Decompensated liver cirrhosis - Contraindication to magnetic resonance imager(MRI) - Malignancy or other systemic disease - Pregnancy |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Korea University Guro Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Korea University Guro Hospital |
Korea, Republic of,
Banerjee R, Pavlides M, Tunnicliffe EM, Piechnik SK, Sarania N, Philips R, Collier JD, Booth JC, Schneider JE, Wang LM, Delaney DW, Fleming KA, Robson MD, Barnes E, Neubauer S. Multiparametric magnetic resonance for the non-invasive diagnosis of liver disease. J Hepatol. 2014 Jan;60(1):69-77. doi: 10.1016/j.jhep.2013.09.002. Epub 2013 Sep 12. — View Citation
Brunt EM, Janney CG, Di Bisceglie AM, Neuschwander-Tetri BA, Bacon BR. Nonalcoholic steatohepatitis: a proposal for grading and staging the histological lesions. Am J Gastroenterol. 1999 Sep;94(9):2467-74. — View Citation
Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ. The diagnosis and management of non-alcoholic fatty liver disease: practice Guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Hepatology. 2012 Jun;55(6):2005-23. doi: 10.1002/hep.25762. — View Citation
Ishak K, Baptista A, Bianchi L, Callea F, De Groote J, Gudat F, Denk H, Desmet V, Korb G, MacSween RN, et al. Histological grading and staging of chronic hepatitis. J Hepatol. 1995 Jun;22(6):696-9. Review. — View Citation
Kleiner DE, Brunt EM, Van Natta M, Behling C, Contos MJ, Cummings OW, Ferrell LD, Liu YC, Torbenson MS, Unalp-Arida A, Yeh M, McCullough AJ, Sanyal AJ; Nonalcoholic Steatohepatitis Clinical Research Network. Design and validation of a histological scoring system for nonalcoholic fatty liver disease. Hepatology. 2005 Jun;41(6):1313-21. — View Citation
Park YS, Lee CH, Kim JH, Kim BH, Kim JH, Kim KA, Park CM. Effect of Gd-EOB-DTPA on hepatic fat quantification using high-speed T2-corrected multi-echo acquisition in (1)H MR spectroscopy. Magn Reson Imaging. 2014 Sep;32(7):886-90. doi: 10.1016/j.mri.2014.04.010. Epub 2014 Apr 24. — View Citation
Piechnik SK, Ferreira VM, Dall'Armellina E, Cochlin LE, Greiser A, Neubauer S, Robson MD. Shortened Modified Look-Locker Inversion recovery (ShMOLLI) for clinical myocardial T1-mapping at 1.5 and 3 T within a 9 heartbeat breathhold. J Cardiovasc Magn Reson. 2010 Nov 19;12:69. doi: 10.1186/1532-429X-12-69. — View Citation
Poynard T, Lenaour G, Vaillant JC, Capron F, Munteanu M, Eyraud D, Ngo Y, M'Kada H, Ratziu V, Hannoun L, Charlotte F. Liver biopsy analysis has a low level of performance for diagnosis of intermediate stages of fibrosis. Clin Gastroenterol Hepatol. 2012 Jun;10(6):657-63.e7. doi: 10.1016/j.cgh.2012.01.023. Epub 2012 Feb 14. — View Citation
SCHEUER PJ, WILLIAMS R, MUIR AR. Hepatic pathology in relatives of patients with haemochromatosis. J Pathol Bacteriol. 1962 Jul;84:53-64. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development of scoring system for diagnosis of NASH | Development of scoring system for diagnosis of NASH using cox regression analysis | up to 24 months | |
Secondary | Evaluation of hepatic fibrosis using fibroscan | Assessment of hepatic fibrosis using fibroscan with transient elastography (kilopascals) (kPa) | up to 24 months | |
Secondary | Evaluation of hepatic steatosis using fibroscan | Assessment of hepatic steatosis using fibroscan with CAP (Controlled Attenuation Parameter) (dB/m) | up to 24 months | |
Secondary | Evaluation of hepatic fibrosis using MRI | Assessment of hepatic fibrosis using MRI with MR elastography (MRE) (kPa) | up to 24 months | |
Secondary | Evaluation of hepatic steatosis using MRS | Assessment of hepatic steatosis using fibroscan with MR spectrography (MRS) (%) | up to 24 months | |
Secondary | Evaluation of hepatic fibrosis using serologic marker | Assessment of hepatic fibrosis using AST to Platelet Ratio Index (APRI) | up to 24 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03375008 -
Predictable MR Index for Nonalcoholic Steatohepatitis (NASH)
|
N/A | |
Recruiting |
NCT05979779 -
Ph 2 Study of the Safety and Efficacy of Three HU6 Dose Levels and Placebo in Nonalcoholic Steatohepatitis
|
Phase 2 | |
Withdrawn |
NCT02769091 -
A Study in Adult Patients With Nonalcoholic Steatohepatitis Who Also Have Type 2 Diabetes
|
Phase 2 | |
Completed |
NCT02654977 -
CLINICAL PROTOCOL to Investigate the Long-term Safety and Efficacy of Metreleptin in Various Forms of Partial Lipodystrophy
|
Phase 2 | |
Recruiting |
NCT05211284 -
Saroglitazar Magnesium 4 mg for NASH in People Living With HIV in the US
|
Phase 2 | |
Completed |
NCT02421094 -
Clinical Trial to Evaluate Efficacy of GR-MD-02 for Treatment of Liver Fibrosis in Patients With NASH With Advanced Fibrosis
|
Phase 2 | |
Completed |
NCT01205087 -
Safety and Efficacy of Oral Administration of Anti-CD3 Monoclonal Antibody (mAb)in Patients With the Metabolic Syndrome
|
Phase 2 | |
Recruiting |
NCT00152711 -
Impact of nCPAP Treatment on Liver Function in Patients With Sleep Apnea Syndrome and Nonalcoholic Steatohepatitis
|
N/A | |
Completed |
NCT02217475 -
Efficacy and Safety Study of Cenicriviroc for the Treatment of Nonalcoholic Steatohepatitis (NASH) in Adult Participants With Liver Fibrosis
|
Phase 2 | |
Completed |
NCT04031729 -
Aspirin for the Treatment of Nonalcoholic Fatty Liver Disease
|
Phase 1/Phase 2 | |
Completed |
NCT03674476 -
An Investigational Study to Evaluate Experimental Medication BMS-986036 in Participants With Different Levels of Kidney Function
|
Phase 1 | |
Terminated |
NCT04565717 -
A Study of ALN-HSD in Healthy Adult Subjects and Adult Patients With Nonalcoholic Steatohepatitis (NASH)
|
Phase 1 | |
Completed |
NCT01679197 -
Clinical Protocol to Investigate the Efficacy of Recombinant Human Leptin (Metreleptin) in Nonalcoholic Steatohepatitis (NASH) or Nonalcoholic Fatty Liver Disease (NAFLD) Associated With Lipodystrophy
|
Phase 2 | |
Active, not recruiting |
NCT05084404 -
Efficacy and Safety of Guanabenz for Nonalcoholic Fatty Liver Disease
|
Phase 2 | |
Active, not recruiting |
NCT02574325 -
A Study to Assess ARI-3037MO on Hepatic Fat Metabolism in Patients With Dysglycemia and Evidence of Hepatic Steatosis
|
Phase 2 | |
Terminated |
NCT00878592 -
Effect of Dietary and Life Style Modification on Post Liver Transplant Obesity
|
N/A | |
Recruiting |
NCT02148471 -
Fatty Acids, Genes and Microbiota in Fatty Liver
|
N/A | |
Completed |
NCT00227110 -
Role of Pioglitazone in the Treatment of Non-alcoholic Steatohepatitis (NASH)
|
Phase 4 | |
Completed |
NCT03656744 -
A Study of HTD1801 in Adults With Nonalcoholic Steatohepatitis (NASH) and Type 2 Diabetes Mellitus (T2DM)
|
Phase 2 | |
Completed |
NCT03068078 -
A Reduced-carbohydrate Diet High in Monounsaturated Fats in Type 2 Diabetes
|
N/A |