Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Be part of new liver disease research!

The AURORA study at MGH is currently enrolling participants with liver fibrosis due to non-alcoholic steatohepatitis (NASH) for evaluation of an investigational oral drug, cenicriviroc (CVC).

Massachusetts General Hospital Liver Diseases Clinical Trials Metabolic Disorders
8 years
Estimated Time Commitment
Male, Female, Gender-expansive, 18-75 years
May Be Eligible
Payment up to $950
May Be Offered
Survey, Blood draw, Medication, Office visit, Sedation, Biopsy
May Be Required
 
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This project is not recruiting.

Overview

What we are studying

The AURORA study is designed to assess the safety and efficacy of an investigational drug called cenicriviroc (CVC) compared to placebo in treating liver fibrosis in adult patients who have non-alcoholic steatohepatitis (NASH).


Why it is important

There are no medications currently approved for the treatment of NASH. Researchers are working toward changing that by conducting clinical trials.


What we hope to accomplish

We hope that this important research will help to expand our understanding and clinical knowledge about NASH and liver fibrosis, with the hope of paving the way for better treatment options within this community of patients.

Principal Investigator

Kathleen Corey, MD

Massachusetts General Hospital

Public Profile

Who can participate

You may be able to participate if you are:



  • 18-75 years old

  • Diagnosed with NASH stage 3 fibrosis on liver biopsy 


Patients must be willing and able to undergo a liver biopsy during the screening period, if they have not had a liver biopsy performed within the past 6 months. YYou will also meet with a doctor from the
study team to review your medical history and make sure that you meet the criteria for taking part in this
study.

Who cannot participate

Females who are pregnant, trying to become pregnant, or breastfeeding cannot participate in the trial. 

What you may be asked to do

Over the course of the visits for the AURORA study, you may be asked to:



  • Provide blood and urine samples

  • Have a fibroscan performed

  • Undergo liver biopsies

  • Have your vital signs measured (including height, weight, waist, and hip)

  • Complete ECG tests

  • Answer questions about your medical and/or family history

  • Complete questionnaires


Project activities may include:

  • Survey
  • Blood draw
  • Medication
  • Office visit
  • Sedation
  • Biopsy

Estimated Time Commitment

8 years

What You May Get

Participants may receive up to $25.00 for each completed study visit.

Location

GI Associates, Blake 4, Massachusetts General Hospital
55 Fruit Street, Boston, MA 02114

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Travel

  • Parking reimbursed
  • Accessible by public transportation
  • Parking available

Travel and Parking Details

Additional Information

Project Website

http://aurorafornash.com


ClinicalTrials.gov Identifier

NCT03028740


Study Phase

Phase 3: This project studies a drug or treatment that has already been studied for safety and effectiveness in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about safety and effectiveness. It may look specifically at different groups of people, different dosages, or different combinations of medications or treatments.


Participating Institutions


Funding Source

  • Industry
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