Liver Stiffness Measurement by Transient Elastography for the Prediction of Fibrosis in Patients with Primary Sclerosing Cholangitis in a Randomized Trial of Simtuzumab

Bowlus, Christopher L.; Montano-Loza, A.J.; Invernizzi, Pietro; Chazouillères, O.; Hirschfield, G.M.; Metselaar, H.J.; Goodman, Z.; Myers, Robert P.; Vera, Raúl A. Aguilar; Subramanian, G. Mani; McHutchison, John G.; Chapman, R.W.; Muir, A.; Eksteen, Bertus; Levy, Carol J.

doi:10.1016/s0168-8278(16)00710-8

Cited by 6 publications

(4 citation statements)

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“…Baseline data on VCTE from a phase 2 simtuzumab trial were recently presented (http://ClinicalTrials.gov NCT01672853). In line with and using the same cutoff as Corpechot et al, baseline transient elastography (TE) had a negative predictive value of 100% for distinguishing Ishak F0‐F4 from F5‐F6, thereby effectively excluding cirrhosis . VCTE meets several desired qualifications for a biomarker, in that it is a practical, cheap, rapid, noninvasive bedside measure and is reproducible.…”

Section: Potential Biomarkersmentioning

confidence: 50%

“…In line with and using the same cutoff as Corpechot et al, baseline transient elastography (TE) had a negative predictive value of 100% for distinguishing Ishak F0-F4 from F5-F6, thereby effectively excluding cirrhosis. (59) VCTE meets several desired qualifications for a biomarker, in that it is a practical, cheap, rapid, noninvasive bedside measure and is reproducible. VCTE has been approved by the FDA for measuring kilopascals (kPa) accurately on the basis of tests carried out in phantoms with known attenuations.…”

Section: Elastographymentioning

confidence: 99%

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Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis

et al. 2018

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Primary sclerosing cholangitis (PSC) is a rare and chronic liver disease for which there is no effective therapy. Interest has grown in developing treatments for this condition, with several agents proposed as potential therapies. However, there is a lack of clarity about how to measure clinical benefit in trials involving patients with this complex and rare disease. This article reviews regulatory information, the available literature on natural history, as well as potential candidate clinical and surrogate endpoints for PSC. (Hepatology 2018; 00:000-000).

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Section: Potential Biomarkersmentioning

confidence: 50%

Section: Elastographymentioning

confidence: 99%

Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis

et al. 2018

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“…In vitro studies demonstrate reduced hepatic fibrosis and rapid reversal of fibrosis with simtuzumab therapy 89. Simtuzumab has already showed promising results when applied to patients with primary sclerosing cholangitis and is currently being studied in patients with NASH and F2-F3 fibrosis 90. Liraglutide is a glucagon-like peptide 1 inhibitor used for type 2 diabetes, and has been shown to improve liver histology in small trials 91.…”

Section: Medicationsmentioning

confidence: 99%

“… 89 Simtuzumab has already showed promising results when applied to patients with primary sclerosing cholangitis and is currently being studied in patients with NASH and F2-F3 fibrosis. 90 Liraglutide is a glucagon-like peptide 1 inhibitor used for type 2 diabetes, and has been shown to improve liver histology in small trials. 91 In a larger randomized controlled trial with 80 patients, 6 months of liraglutide therapy has been shown to reduce liver fat compared to placebo.…”

Section: Medicationsmentioning

confidence: 99%

Perspectives on Nonalcoholic Fatty Liver Disease: An Overview of Present and Future Therapies

Vizuete¹,

Camero²,

Malakouti³

et al. 2017

Journal of Clinical and Translational Hepatology

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Nonalcoholic fatty liver disease (NAFLD) represents a major public health epidemic. Pharmacologic therapies for this condition are scarce, but multiple agents with novel mechanisms of action are in development. Here we review the pathophysiology and natural history of NALFD, diagnostic testing and data for currently available treatment strategies. We then turn our attention to promising developmental drugs and their respective trials. As the prevalence of fatty liver disease increases, clinicians will have more tools at hand for management of this condition. We conclude the horizon is bright for patients and doctors who deal with NAFLD. Citation of this article: Vizuete J, Camero A, Malakouti M, Garapati K, Gutierrez J. Perspectives on nonalcoholic fatty liver disease: an overview of present and future therapies.

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New therapeutic perspectives in non-alcoholic steatohepatitis

Ampuero

Sánchez‐Torrijos

Aguilera

et al. 2018

Gastroenterología y Hepatología (English Edition)

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Management of non-alcoholic steatohepatitis is focused on restitution of metabolic derangement, weight loss and drugs able to improve steatosis, ballooning and fibrosis. Life-style interventions based on Mediterranean diet and increasing physical activity are the first line therapy. In patients with unsuccessful life-style intervention several drugs are under development: agonist PPAR, agonist GLP-1R and agonist FXR together with drugs focussing on inflammation, ballooning, apoptosis and fibrosis. Bariatric surgery or advanced endoscopy are reserved for morbid obese without response to life-style intervention and weighting loss drugs.

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Liver Stiffness Measurement by Transient Elastography for the Prediction of Fibrosis in Patients with Primary Sclerosing Cholangitis in a Randomized Trial of Simtuzumab

Cited by 6 publications

References 0 publications

Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis

Design and Endpoints for Clinical Trials in Primary Sclerosing Cholangitis

Perspectives on Nonalcoholic Fatty Liver Disease: An Overview of Present and Future Therapies

New therapeutic perspectives in non-alcoholic steatohepatitis

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