As of 18 March 2020, Roche’s tominersen studies are ongoing, including the Phase III GENERATION-HD1 study which continues to enrol people with Huntington’s disease across the UK. As the global COVID-19 outbreak evolves, our focus is ensuring both patient safety and data integrity. Roche is working with trial sites to mitigate risks where possible and we are reviewing the situation on an ongoing basis.
COVID-19 is a new strain of coronavirus, so evidence about how it may affect people with Huntington’s disease is currently unavailable. If anyone has concerns about receiving trial treatment they should speak to their clinician for the latest information.
We advise patients and families participating in our clinical studies to follow the advice provided by their clinical trial site and abide by any guidance issued by the local authorities in relation to attending their scheduled appointments. Decisions about health and safety should be determined by the patient and their treating physicians.
If a patient cannot attend their scheduled appointments, they should contact their site immediately to inform them, and remain in regular telephone contact. Participants in the trials should continue to use the Roche HD app and complete the assessments.
If patients believe they are displaying symptoms of, or have been diagnosed with, COVID-19 they should inform their treating physician that they are on a clinical trial. They should also contact their clinical trial site, who will be able to advise on the local protocol.
Patient safety is Roche’s highest priority and we are closely monitoring the evolving COVID-19 situation. We will update you if there are any changes in the global situation that may impact on the tominersen ongoing trials.
Any adverse events should be reported to Roche Products Ltd. Please contact Roche Drug Safety Centre by emailing welwyn.uk_dsc@roche.com or calling 01707 367554.
