Safety and Efficacy of Turoctocog Alfa in Previously Treated Male Children With Haemophilia A (guardian™ 3)

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Haemophilia A; Congenital Bleeding Disorder

Treatments: Drug: turoctocog alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01138501

U1111-1113-7182 (Other Identifier)

NN7008-3545

2009-016383-36 (EudraCT Number)

Details and patient eligibility

About

This trial is conducted in Asia, Europe, and North and South America. The aim of this clinical trial is to investigate the safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in male previously treated paediatric subjects with haemophilia A.

Enrollment: 65 patients

Sex: Male

Ages: Under 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients with severe (baseline FVIII less than or equal to 1%) haemophilia A
• Age below 12 years and weight at least 11 kg

Exclusion criteria

• Surgery planned to occur during trial participation (exceptions are port placement, dental extractions, and minor, uncomplicated emergent procedures)
• Congenital or acquired coagulation disorders other than haemophilia A
• Any history of FVIII inhibitors (greater than or equal to 0.6 BU/mL)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

rFVIII

Experimental group

Treatment:

Drug: turoctocog alfa

Drug: turoctocog alfa