Itchiness is a lesser known aspect of PBC liver disease that can impact sleep, mood and activities of daily living for patients. A clinical trial is researching the ability of an investigational medicine to treat PBC related itchiness.
Clinical trials (also called clinical research) are research studies to determine whether investigational drugs or treatments are safe and effective for humans. All investigational medications and devices must undergo clinical trials before they are made available to patients.
Before you can participate in any clinical trial, you will be asked to review and sign an informed consent form (ICF), which will explain the potential benefits, risks, and side effects that you may experience while taking part in the clinical trial. Signing it indicates you are agreeing to take part in this research study.
You can decide to leave a clinical trial at any time, and you do not have to give a reason. There is no charge or penalty if you decided not to take part in a clinical trial.
You will have access to investigational medications that, if approved, will be available by prescription to the general public. You will also receive study-related medical care and attention from clinical trial staff at research facilities. Clinical trials offer an opportunity to help researchers find better treatments for others in the future.
The investigational treatment may or may not help to make your condition better. While you may have a positive trial experience, you may also experience unpleasant or serious side effects. It's important to discuss the benefits and risks with either your doctor or the clinical trial site contact before making any decisions.
Your information will be kept confidential within the limits of the law of your country. If the results of this clinical trial are published or presented in a meeting, you will not be named and nobody will be able to tell that you were in the trial from the publication or presentation.
If you would like to speak to someone regarding this trial, first check to see if you meet the basic criteria above. If you meet the criteria and are interested in learning more about determining your eligibility we can contact you by phone to discuss additional eligibility requirements, discuss your interest and answer questions you may have about the clinical trial.