Investigation of the Pharmacokinetics of Turoctocog Alfa in Subjects With Haemophilia A

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

NCT01692925

U1111-1129-1517 (Other Identifier)

NN7008-4015

2012-001444-21 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Europe. The aim of the trial is to investigate the pharmacokinetics (the exposure of the trial drug in the body) of four lots of turoctocog alfa (a human recombinant coagulation factor VIII (FVIII)) in subjects with haemophilia A.

Enrollment: 15 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Male subjects with the diagnosis of severe haemophilia A (FVIII<1%) from age 18 years
• Documented history of at least 150 exposure days to any other FVIII products (prevention or treatment of bleeds)
• Immunocompetent (HIV (Human Immunodeficiency Virus) positive subjects should have CD4+ (Cluster of differentiation 4; a glycoprotein expressed on the surface) lymphocyte count >200/microL)

Exclusion criteria

• Detectable inhibitors to FVIII (above or equal to 0.6 Bethesda Units (BU))
• History of FVIII inhibitors
• Severe current hepatic dysfunction or severe hepatic disease during the last 12 months
• Known or suspected allergy to trial product (FVIII) or related products
• Subjects receiving immune modulating medication or immune tolerance induction (ITI) regimens
• Body mass index (BMI) above 30 kg/m^2

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 4 patient groups

Lot A

Experimental group

Description:

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Treatment:

Drug: turoctocog alfa

Drug: turoctocog alfa

Lot B

Experimental group

Description:

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Treatment:

Drug: turoctocog alfa

Drug: turoctocog alfa

Lot C

Experimental group

Description:

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Treatment:

Drug: turoctocog alfa

Drug: turoctocog alfa

Lot D

Experimental group

Description:

Each subject will receive two single doses of turocotocog alfa from two lots of trial product on two separate days.

Treatment:

Drug: turoctocog alfa

Drug: turoctocog alfa