The AURORA nash study
Why is this study being conducted?
This study is designed to assess the safety and efficacy of an investigational drug called cenicriviroc (CVC) compared to placebo in treating liver fibrosis (scar tissue) in adult patients who have non-alcoholic steatohepatitis (NASH).. 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 within this community of patients in the future.
What is the investigational drug?
The drug this study is investigating is called Cenicriviroc (CVC), which is in pill form.
CVC is believed to work in treating NASH by blocking the process of inflammation in the liver. As prolonged inflammation can lead to irreversible scarring, cirrhosis and liver failure, CVC may be able to help prevent or slow down the progression of the disease and delay permanent liver damage.
What happens during the study?
A total of 2000 participants will be enrolled to participate in the study.
If you are potentially eligible, have spoken with one of the study doctors to learn more and are in agreement to participate, you will be asked to sign an Informed Consent Form which provides details about your participation and expectations.
Once consented, the first stage of the study is Screening. This takes place about 8 weeks before you may receive study drug and includes numerous assessments to confirm you are eligible to take part in the study.
The AURORA study will be completed in two parts: Part 1 and Part 2. You may participate in either Part 1, Part 2 or both Parts, depending on when you enter the study.
In Parts 1 and 2, you will be randomly assigned to receive either CVC or placebo. You will have a 2 to 1 chance of receiving active drug CVC versus placebo. Neither you, nor your study staff or doctor will know which you have been assigned to. This is call “blinding” and is used to fairly compare the efficacy and safety of the investigational drug.
Part 1 of the study will last approximately 12 months after receiving your first dose of study drug, and you will return to the study center 6 times during Part 1 of the study. If you continue in the study after completing Part 1, you will enter Part 2, and you will continue to receive the same study drug as in Part 1. In Part 2 you will return to the study center every 3 months. Part 2 of the study will last approximately 7 years (84 months). If you start the study directly in Part 2, the study will last approximately 7 years (84 months). After your eligibility has been confirmed you will have 6 visits to the study center for the first year and then every 3 months thereafter.