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Physician_CA209-9DX

Test landing page for physicians

What is a clinical research study?

Clinical research studies explore whether a study drug is safe and effective for patients. Study drugs are approved (or rejected) for medical use by health authorities based on data from clinical research studies.

Clinical research studies are important because they:

  • Help answer specific health questions
  • Help improve patient care
  • Help advance medical knowledge

What are the current treatment options?

Currently, there are no approved treatment options for NASH. Many doctors recommend losing weight, as research suggests this helps to reduce the liver fat and scarring associated with the condition. However, many people struggle to make such lifestyle changes. Because of this, there is a significant need for new NASH drugs to be developed.

  • More about how clinical trials work

    Who oversees clinical trials?

    To help ensure that a clinical trial is ethical and that participants' rights are protected, Institutional Review Boards (IRB) or Ethics Committees (EC) review and approve clinical trial protocols that detail all aspects of how the study is conducted. In addition, study monitors, also known as clinical research associates, visit the study clinics to confirm the study protocol procedures and clinical trial requirements and regulations are being followed throughout the study. Health authorities may also inspect the study clinics to ensure the safety and rights of participants in a trial and the integrity of the clinical trial objectives are being maintained.

    Who can participate in a clinical trial?

    Only participants who meet all required eligibility criteria for a clinical trial may take part. The study team at the clinic you select will review your medical history and current medical status against the eligibility criteria. They will determine if you are eligible to participate in the trial. You may also be asked to provide information from your medical records to help the study team determine if you could be eligible.

    What is an investigational drug?

    An investigational drug is a product that has not yet been approved by appropriate regulatory authorities (e.g., the U.S. Food and Drug Administration) for medical
  • About the investigational Drug

    What is the name of the investigational drug?

    Because this drug is still being evaluated and has not been approved by a health authority, it does not have a name. Instead, it is referred to as pegbelfermin.

    Why is the investigational drug being studied?

    The investigational drug is being evaluated to see if it is safe and effective at reducing the liver damage caused by NASH

    What is a placebo?

    A placebo looks like the investigational drug but is an inactive substance. It is used in clinical trials to determine if the investigational drug is more effective than no treatment at all. It also helps to assess the safety of the investigational drug.
  • Privacy, Participation and Reimbursement

    What happens to personal information?

    The study team respects and protects your privacy and will not share your personally identifiable information except as required by law. Your identity will not be revealed in any study report or publication. The study team will store your personally identifiable information with codes that do not identify you. The Informed Consent Form will provide more information about how your privacy will be maintained.

    Can I withdraw from the clinical trial after I have started?

    Your participation in the clinical trial is entirely voluntary, and you may withdraw at any time. If you decide to withdraw early from the study, you will be asked to notify the study team before doing so. You will be asked to return to the clinic at least once to complete a final visit and return any unused investigational drug.

    Do I have to pay to participate in the clinical trial?

    There is no charge for taking part. All study-related assessments and the investigational drug are provided at no charge. You may be responsible for other costs (for example, tests you would receive as part of regular care for your condition), some of which may be covered by your insurance.

    Will I be paid for taking part/ reimbursed for travel?

    You will not be paid for taking part in the clinical trial. You may be responsible for other costs (for example, tests you would receive as part of regular care for your condition), some of which may be covered by your insurance. The study team can inform you about reimbursement for reasonable travel expenses incurred to attend study visits if you are eligible and are referred to a clinic.

    Does my doctor have to give his/ her permission?

    Your doctor does not have to give his/her permission for you to take part. However, either you or the study doctor, with your permission, may contact your personal doctor to discuss your participation before you begin and keep him/her up to date about your progress.
  • More about NASH

    What is NASH

    Non-alcoholic steatohepatitis (NASH) is a disease that affects people who have an inflamed and damaged liver due to the build-up of fats in their liver. Although many people with NASH experience few symptoms, it often results in scarring of the liver known as ‘fibrosis.’ Over time, fibrosis can progress to cirrhosis of the liver.

    What is Cirrhosis?

    Cirrhosis is the liver damage caused when scar tissue replaces normal tissue and it is the main complication of NASH. It can take many years to develop, often without any noticeable symptoms. There are 2 main stages of cirrhosis – compensated and decompensated. Compensated cirrhosis means that the liver is heavily scarred but can still perform many of its important functions. Too much scarring and the liver will run out of healthy cells to function properly – this is decompensated cirrhosis, which can result in liver failure.

    What are early symptoms of compensated cirrhosis?

    Symptoms may include: Fatigue and loss of energy, loss of appetite and weight loss, nausea or abdominal pain, spider angiomas may develop on the skin (these are pinhead-sized red spots from which tiny blood vessels radiate outward)

We strongly recommend you contact BMS to report Side Effects (Adverse Events)
Side Effects (Adverse Events) and other reportable events are defined here
Report Side Effects (Adverse Events) or Product Quality Complaints: Medical Information

Have questions? Live support is available 24/7 - Call 855-907-3286 or email clinical.trials@bms.com

Have questions? Live support is available 24/7 -
Call 855-907-3286 or email clinical.trials@bms.com