Guardian 9

Principal Investigator: Hassan Yaish
Keywords: Pharmacokinetics , NovoEight , Turoctocog Alpha , Haemophilia Department: Pediatric Administration
IRB Number: 00096577 Co Investigator:  
Specialty: Pediatrics, General
Sub Specialties:
Recruitment Status: Recruiting

Contact Information

Rebbecca Hanshew
Rebbecca.Perez@hsc.utah.edu
801-213-9105

Brief Summary

The overall objective of the trial is to evaluate the pharmacokinetics (PK) of turoctocog alfa in relation to body composition in patients with severe haemophilia A with a range of BMI.

Inclusion Criteria

1. Informed consent obtained before any trial-related activities. Trial-related activities are any
procedures that are carried out as part of the trial, including activities to determine suitability for
the trial.
2. Male, age ~18 years at the time of signing informed consent.
3. History of more than 150 exposure days to any factor VIII products.
4. Subjects with the diagnosis of congenital haemophilia A with factor VIII activity <1 %, based on
medical records.
5. Immunocompetent (CD4+ T cells >200/μL at screening).

Exclusion Criteria

1. Known or suspected hypersensitivity to trial products or related products.
2. Previous participation in this trial. Participation is defined as signed informed consent.

3. Receipt of any investigational medicinal product except turoctocog alfa within 30 days before
administration of trial product.
4. Any disorder which in the opinion of the investigator might jeopardise the subject's safety or
compliance with the protocol.
5. Known history of factor VIII inhibitors.
6. Inhibitors to factor VIII (::>:0.6 BU) at screening measured by the Nijmegen modified Bethesda
method.
7. Known congenital or acquired coagulation disorders other than haemophilia A.
8. Mental incapacity, unwillingness to cooperate, or a language barrier precluding adequate
understanding and cooperation.
9. Previous participation in pharmacokinetic sessions with turoctocog alfa in another trial.