March 4, 2026
Thank you for all your efforts on this study so far!
The IRT system now allows the transition to Monthly visits at Week 26, Week 30, or Week 34. Previous supply contained Autoinjectors needed for Week 34 and beyond. Sites will begin to receive Autoinjector resupply for Week 26 and Week 30 visits in the coming week. Your site may need to wait for resupply to arrive before transitioning patients at Week 26 or Week 30.
Per the protocol, participants may switch at Week 26, Week 30, or Week 34. If your site is waiting on supplies needed for the transition to Autoinjectors, participants may wait until Week 34 to transition.
Please see a previously sent email for the Vanquish 1 site FAQ/Discussion Guide for your reference. This is a tool to aid discussions with participants who are at risk of dropping out of the study.
Just a friendly reminder to ensure consideration is taken for the time change upcoming on 08Mar2026. If the IP will be administered on the 5th day, please be mindful of the lost hour due to the time change to ensure a full 120 hours is met between doses.
Additionally, please also make sure any clocks used to document time are appropriately updated.
Please see attached the MCL guidance to ensure ECG machines are updated. It will be the site’s responsibility to ensure the time is correct prior to any participant visits.
We have seen and are aware of multiple versions of the consent form being released in a rapid period due to errors made by Advarra during IRB finalization of the updated consent corresponding with PAV5.0. Medpace is working to obtain additional guidance from Advarra on reconsenting requirements and additional details are forthcoming. Thank you for your patience and understanding.
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