The mission of our clinical research is to foster discoveries in the novel therapies of inflammatory bowel diseases, gastrointestinal and pancreatic cancer, hepatitis, and other gastrointestinal disorders. Our doctors are committed to providing the best care and management of diseases while testing cutting-edge therapies.

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Ongoing clinical trials for liver disease: Actively recruiting


Condition:

Non-alcoholic steatohepatitis

Study title:

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)

Description of study:

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

Principal Investigator:

Kathleen Corey, MD, MPH

Contact:

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


Condition:

Non-alcoholic steatohepatitis

Study title:

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)

Description of study:

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

Principal Investigator:

Kathleen Corey, MD, MPH

Contact:

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


Condition:

Lysosomal Acid Lipase Deficiency (LALD)

Study title:

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

Description of study:

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.

Principal Investigator:

Kathleen Corey, MD, MPH

Contact:

Kathleen Corey; 617-724-1685


Condition:

Non-Alcoholic Fatty Liver Disease

Study title:

Non-Alcoholic Fatty Liver Disease Registry

Description of study:

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.

Principal Investigator:

Kathleen Corey, MD, MPH

Contact:

Kyle Malecki; 617-726-3670


Condition:

Liver Disease

Study title:

Liver Disease Tissue Repository

Description of study:

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.  

Principal Investigator:

Ray Chung, MD

Contact:

Kyle Malecki; 617-726-3670