The following Patient information sheets are available from your local clinic if you would like more information about the study:
- Children ages 2 to 6 years
- Children aged 7 to 11 years
- Children ages 12 to 15 years
- Adults from 16 years
- Legal Guardian
If you would like to take part in the study, the possible benefits are:
It might mean that you will no longer need to take the Eculizumab treatment and face any potential risks or side effects associated with treatment.
Patients are about a thousand times more likely to develop a serious, potentially life threatening infection with meningococcus, a bug that causes meningitis or sepsis.
Vaccination, and even antibiotics, do not give complete protection from this.
Other serious problems have also been reported in patients taking Eculizumab but we cannot be certain that Eculizumab was the cause of these problems.
Being in the study will mean that you will no longer need bi-weekly infusions and will not have to continue taking additional antibiotics to prevent infection.
However, it is possible that you could need to restart and continue Eculizumab if a relapse was to occur.
The possible risks of taking part in the study:
The withdrawal of Eculizumab treatment could lead to a relapse of atypical HUS and relapse associated complications.
When a relapse is diagnosed, your Eculizumab treatment will be restarted within 24 hours of presentation.
It is essential that you present to a hospital with your patient card as soon as you begin to feel unwell or the home urine test shows an increase in the level of blood.
This is to ensure that the Eculizumab is re-started as soon as possible to reduce the likelihood of kidney damage and associated complications.
If your treatment is re-started, you will receive your first infusion in the hospital.
You will also have the antibiotics restarted to protect you from infection.
If you need to be put back on to Eculizumab treatment you can decide to receive your infusions in hospital or at home.
This can be arranged with your clinical team if you relapse while in the study.
If a relapse occurs this could lead to a drop in kidney function or other problems related to the disease which can affect organs such as the pancreas or nervous system.
The evidence that is available at the moment suggests that if Eculizumab is reintroduced quickly these problems can be avoided.
This is not proven and this study will test whether this is true.