frequently asked questions
What is Informed Consent?
An Informed Consent document will be given to you before you join the study. This document outlines the key facts about a research study, including the risks and benefits of taking part, so you can consider what is involved, ask any questions and decide if you are in agreement to go ahead and sign the document. No study-related procedures will take place without a signed Informed Consent form.
What is a study investigator?
A study investigator is a doctor in charge of conducting a clinical research study and ensuring the wellbeing of study volunteers. The investigators involved with the AURORA research study are all qualified licensed doctors and medical specialists.
What is an investigational drug?
An investigational medicine is a research study drug that has not yet been approved by the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), or similar agencies in other countries, for prescription by doctors.
How will I be given the investigational drug?
You will be provided with bottles of tablets to take at home. You will be given advice on how and when to take your medication by your study doctor. It is a once a day medication to be taken orally with food, unless instructed otherwise by your study doctor.
Will I know what treatment I have been given?
No, this is a double-blind study, so neither you nor your doctor will know if you are taking the placebo or CVC.
What is a placebo?
A placebo is often used in clinical research studies, it is a pill that has no medical effect and is to provide a comparison for the efficacy and safety of investigational medicine. It is a pill/tablet that matches the study drug of interest. The placebo provides a comparison for the effectiveness and safety of the study drug. As a participant, you will either be administered CVC or the placebo for this study.
How often will I have to take the study drug?
Study medication is a once-daily tablet, to be taken orally with food.
Are there any risks involved in joining in the study?
Any risks associated with participation in this study will be reviewed and discussed with your study doctor prior to participation, these will also be clearly outlined in the informed consent form. You may experience side effects, find that your symptoms are not improving or even increasing in severity. It will be important that you report any concerns to your study doctor immediately as they will be able to give you more detailed advice. There are also risks associated with the liver biopsy study procedure, your study doctor will talk you through this procedure and its related risks too.
What are the benefits of taking part?
CVC might help your NASH and liver fibrosis. But, there is no guarantee that this research study will help you. You may learn more about NASH and liver fibrosis while you are in this study. The information that is collected from the research study may help researchers find new treatments for future patients.
What happens if I change my mind about taking part?
You are completely free to leave the study at any time without giving a reason. The decision to leave the study will not affect your future medical care in any way. If you do choose to stop participating in the study, we will ask that you attend a discontinuation visit within 48 hours of taking your last dose of study drug and one visit 30 days after that.
You may also request that the personal information collected via this website is destroyed within 30 days by sending an email to email@example.com
What happens to my personal information?
The personal data collected during the course of the study classifies as ‘data concerning health’, according to the General Data Protection Regulation.
Information about your personal health will be kept strictly private and confidential. With your permission, the information you provide via the pre-screening form on this website about your medical history and health condition will be transferred to the AURORA study site team. Your information will be transferred only for the purpose of enabling a representative from a potential study site near you to contact you to further determine your interest and eligibility. Your personal information will not be disclosed to anyone outside of this clinical research study group without your consent unless disclosure is required by law or regulations of the FDA, EMA, or similar agencies in other countries.
By submitting the eligibility form, you agree that your personal information identified in the form, including sensitive information such as data concerning health, can be processed for the purpose of the study. Your personal data will be processed only to the extent necessary to carry out the study. In addition to this, you agree that your coded data may be transferred to the regulatory and health authorities in your country and may also be sent to other countries outside the EU/EEA where the laws may not protect your personal data to the same extent as the laws in the EU/EEA. If your data is transferred to such countries outside the EEA, the controller of personal data, Allergan, is responsible for taking appropriate steps to protect your personal data and keep it secure and confidential.