Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02941354
• Date of registration: 14/10/2016
• Prospective Registration: No
• Primary sponsor: Novo Nordisk A/S
• Public title: Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A guardian ™9
• Scientific title: A Multicentre, Open-label Trial Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A
• Date of first enrolment: October 10, 2016
• Target sample size: 35
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02941354
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1

Countries of recruitment

Austria, Bulgaria, Germany, Serbia, Spain, Taiwan, United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male, age at least 18 years at the time of signing informed consent

- History of more than 150 exposure days to any factor VIII products

- Subjects with the diagnosis of congenital haemophilia A with factor VIII activity
below 1%, based on medical records

Exclusion Criteria:

- Known history of factor VIII inhibitors

- Inhibitors to factor VIII (above or equal to 0.6 BU (Bethesda units)) at screening
measured by the Nijmegen modified Bethesda method

- Known congenital or acquired coagulation disorders other than haemophilia A

- Previous participation in pharmacokinetic sessions with turoctocog alfa in another
trial



Age minimum: 18 Years
Age maximum: N/A
Gender: Male

Health Condition(s) or Problem(s) studied

Haemophilia A

Congenital Bleeding Disorder

Intervention(s)

Drug: turoctocog alfa

Primary Outcome(s)

Plasma FVIII activity at 30 minutes(C30min) [Time Frame: At 30 minutes post-dose]

Secondary Outcome(s)

Incremental recovery FVIII at 30 minutes (IR30min) [Time Frame: At 30 minutes post-dose]

Apparent volume of distribution at steady state (Vss) of FVIII [Time Frame: From 0 up to 72 hours after administration]

Terminal half-life (t½) of FVIII [Time Frame: From 0 up to 72 hours after administration]

Area under the FVIII activity-time curve [Time Frame: From 0 up to 72 hours after administration]

Clearance (CL) of FVIII [Time Frame: From 0 up to 72 hours after administration]

Secondary ID(s)

NN7008-4239

2015-004379-56

U1111-1175-1191

Source(s) of Monetary Support

Please refer to primary and secondary sponsors