BAX 888 for Hemophilia A
Trial Summary
What is the purpose of this trial?
The main aim of this study is to check if there are side effects from BAX 888 and to determine the dose of BAX 888 for treating severe hemophilia A in male adults.Participants will receive one infusion with BAX 888 at the hemophilia treatment center. During the study, participants will visit their study clinic multiple times.
Research Team
Study Director
Principal Investigator
Shire
Eligibility Criteria
This trial is for male adults aged 18-75 with severe hemophilia A, who have had more than 150 exposure days to FVIII treatments and at least three bleeding episodes in the past year. Participants must be willing to use barrier contraception and comply with study requirements like providing semen samples and keeping a diary of bleeding episodes.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous infusion of BAX 888 at varying doses depending on cohort assignment
Dose Escalation and Expansion
Participants are monitored for FVIII activity levels to determine dose escalation or cohort expansion
Follow-up
Participants are monitored for safety, effectiveness, and immune response after treatment
Treatment Details
Interventions
- BAX 888
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baxalta now part of Shire
Lead Sponsor
Flemming Ornskov
Baxalta now part of Shire
Chief Executive Officer since 2013
MD, MPH
Ludwig N. Hantson
Baxalta now part of Shire
Chief Medical Officer since 2015
PhD
Baxalta Innovations GmbH, now part of Shire
Industry Sponsor
Takeda Development Center Americas, Inc.
Industry Sponsor