Evaluating the Pharmacokinetics of NovoEight® (Turoctocog Alfa) in Relation to BMI in Subjects With Haemophilia A (guardian ™9)

Novo Nordisk

Status and phase: Completed; Phase 1

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: turoctocog alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT02941354

NN7008-4239

U1111-1175-1191 (Other Identifier)

2015-004379-56 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Turoctocog alfa

Experimental group

Treatment:

Drug: turoctocog alfa