General Trial Questions
How long will I be in the trial?
You will be in the trial about 16.5 months.
How many times will I have to go to the trial site?
During the trial, you will have up to 22 trial visits. During the trial visits, you will have tests and procedures.
Do I have to attend all trial visits?
It’s important to attend all scheduled visits to check on your health and to see how the trial treatment may be affecting you.
What are the benefits of being in the clinical trial?
You may or may not directly benefit from being in the clinical trial. However, your health will be monitored regularly throughout the trial by doctors with expertise in liver disease. Any information collected during the trial may help doctors learn more about treating others with similar alcohol-related health problems in the future.
Will it cost me anything to be in the trial?
You do not have to pay to take part in this trial. You will get the trial drug and all the trial tests and procedures at no cost.
Who is sponsoring the trial?
The global biopharma company GlaxoSmithKline is sponsoring the trial. They pay the staff at the trial site to run this trial.
What if I decide to join the trial and then change my mind?
Being in the trial is voluntary. If you decide to join and then change your mind, you can leave the trial at any time. Leaving the trial will not affect your regular medical care.
Trial Treatment Questions
What trial treatment will I receive?
If you qualify for the trial, you will be assigned by chance to receive either the trial drug or the placebo. The placebo looks just like the trial drug but does not contain active medicine.
How are the trial treatment groups assigned?
A computer system will be used to assign participants to trial treatment groups by chance. This is called randomisation.
Will I know what trial treatment I’m receiving?
You and the trial team will not know which trial treatment you are receiving. This helps to keep the trial fair and unbiased.
How does the trial drug work?
The trial drug works by lowering the amount of a protein made in the liver that is thought to be involved in the development and worsening of ALD. By lowering the amount of this protein, the trial drug may be able to reduce the toxic effects of alcohol on the liver.
Are there any side effects from the trial drug?
As with all medicines, there is a chance for side effects, which are unwanted or unintended effects of a medicine. Talk to the trial doctor for more information on possible side effects. Your health will be closely monitored during the entire trial. Inform the trial doctor if you notice any side effects or changes in your health.
Will I still receive the trial treatment if I drink alcohol during the trial?
Stopping alcohol drinking is recommended for people living with liver disease. However, this may not always be possible. You will still be able to participate in this trial even if you have not stopped drinking.