Study design
ITTP, MAY, RECURRENCE
This was a prospective, single-arm, open-label study (NCT04074187) conducted at 11 centers in Japan between October 2019 and May 2021, and sponsored/funded by Sanofi. The primary objective of the study was to evaluate the ability of caplacizumab to prevent the recurrence of iTTP during the overall study period.The protocol and other relevant documents were approved by an Institutional Review Board prior to study initiation. In addition, the study was conducted in accordance with the protocol and ethical principles outlined in international guidelines including the Declaration of Helsinki, and the International Conference on Harmonization Good Clinical Practice Guidelines, as well as any applicable laws, rules, and regulations. Participants, or their legally authorized representative, provided written informed consent prior to any study procedures being undertaken.