Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A
NCT02941354 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 35
Last updated 2019-01-30
Summary
This trial is conducted globally. The aim of this trial is evaluating the pharmacokinetics (the exposure of the trial drug in the body) of NovoEight® (turoctocog alfa) in relation to BMI (body mass index) in subjects with haemophilia A.
Conditions
- Congenital Bleeding Disorder
- Haemophilia A
Interventions
- DRUG
-
turoctocog alfa
Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.
Sponsors & Collaborators
- lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-10-10
- Primary Completion
- 2017-06-20
- Completion
- 2017-06-20
- FDA Drug
- Yes
Countries
- United States
- Austria
- Bulgaria
- Germany
- Serbia
- Spain
- Taiwan
Study Locations
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