A Study of BAX 888 in Male Adults With Severe Hemophilia A
NCT03370172 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 4
Last updated 2025-09-11
Summary
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.
Conditions
Interventions
- DRUG
-
BAX 888
Participants will receive a single peripheral IV infusion of BAX 888 in Cohort 1 and 2 Day 0.
Sponsors & Collaborators
-
Baxalta Innovations GmbH, now part of Shire
collaborator INDUSTRY -
Takeda Development Center Americas, Inc.
collaborator INDUSTRY -
Baxalta now part of Shire
lead INDUSTRY
Principal Investigators
-
Study Director · Shire
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-02-27
- Primary Completion
- 2024-07-09
- Completion
- 2024-07-09
- FDA Drug
- Yes
Countries
- United States
- Austria
- France
- Germany
- Hungary
- Spain
Study Locations
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