Factor IX as Adjunctive Therapy to Emicizumab (EMIX)
NCT05281718 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-01-20
Summary
This trial will enroll patients with severe hemophilia A. Experiments will be run in vitro by spiking patients' blood with different molecules (currently used and theoretically proposed as adjunctive therapy to emicizumab), therefore no more than minimal direct risk to patients is expected. This is a pilot preclinical study.
Conditions
Interventions
- DRUG
-
Factor IX
Factor IX is on of the substrates of emicizumab.
Sponsors & Collaborators
-
Genentech, Inc.
collaborator INDUSTRY -
Tulane University
lead OTHER
Principal Investigators
-
Maissa Janbain, MD, MS · Tulane University
Study Design
- Allocation
- NA
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 12 Years
- Max Age
- 120 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-01
- Primary Completion
- 2024-03-07
- Completion
- 2024-07-14
- FDA Drug
- Yes
Countries
- United States
Study Locations
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