Massachusetts General Hospital

Non-alcoholic steatohepatitis

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects with Advanced Liver Fibrosis but not Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

The goal of this study is to see if the monoclonal antibody, GS-6624 is effective at preventing the progression of liver fibrosis in people with NASH.

Basic eligibility criteria:

Adults aged 18-65 with NASH; willing to commit to a 2 year study with visits twice a month. Clinical Trials.gov identifier: NCT01672866

Kathleen Corey, MD, MPH

Jenna Gustafson: 617-724-3836 and Kyle Malecki: 617-726-3670

Non-alcoholic steatohepatitis

A Phase 2b, Dose-Ranging, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of GS-6624, a Monoclonal Antibody Against Lysyl Oxidase-Like 2 (LOXL2), in Subjects with Compensated Cirrhosis Secondary to Non-Alcoholic Steatohepatitis (NASH)

The goal of this study is to see if the monoclonal antibody, GS-6624 is effective at reversing liver scarring and heal cirrhosis in people with NASH.

Basic eligibility criteria:

Adults aged 18-65 with NASH and cirrhosis; willing to commit to a 2 year study with visits twice a month; Clinical Trials.gov identifier: NCT01672879

Kathleen Corey, MD, MPH

Jenna Gustafson: 617-724-3836 and Kyle Malecki: 617-726-3670

Lysosomal Acid Lipase Deficiency (LALD)

A Phase III Multicenter Study of SBC-102 (sebelipase alfa) in patients with Lysosomal Acid Lipase (LAL) Deficiency

Lysosomal acid lipase deficiency (LALD) is a genetic disease characterized by abnormal fat accumulation in many parts of the body due to a decrease in activity of the enzyme lysosomal acid lipase (LAL). The late onset form of the disease occurs in children and adults and can cause cirrhosis and dyslipidemia. Late onset LALD is characterized by an enlarged liver, abnormal liver function tests (LFTs) and elevated cholesterol levels.

The ARISE (Acid Lipase Replacement Investigating Safety and Efficacy) clinical study will evaluate the safety and efficacy of sebelipase alfa (SBC-102, recombinant human LAL) administered every other week as an intravenous infusion in patients with late onset LALD.

Details of the study are available at http://www.clinicaltrials.gov/ct2/show/NCT01757184 or http://www.clinicaltrials.gov (search term “sebelipase alfa”).

Basic eligibility criteria:

Patients diagnosed with suspected LALD can be screened at the MGH Fatty Liver Clinic. Those with LALD may be eligible for enrollment.

Kathleen Corey, MD, MPH

Kathleen Corey; 617-724-1685

Non-Alcoholic Fatty Liver Disease

Non-Alcoholic Fatty Liver Disease Registry

This registry follows patients and family members with suspected or established non-alcoholic fatty liver disease. The purpose of this study is to identify non-invasive ways to diagnosis fatty liver disease as well as attempt to understand the causes of fatty liver disease.

Basic eligibility criteria:

Any patient with either abnormal liver function tests or fatty liver seen on ultrasound, CT scan or MRI is eligible.

Kathleen Corey, MD, MPH

Kyle Malecki; 617-726-3670

Liver Disease

Liver Disease Tissue Repository

This registry follows patients (both adults and children) and family members with suspected or established liver disease of any type.

Basic eligibility criteria:

Any patient with either abnormal liver function tests or with suspected liver disease of any type is eligible.  

Ray Chung, MD

Kyle Malecki; 617-726-3670