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

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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

65 participants in 1 patient group

rFVIII
Experimental group
Treatment:
Drug: turoctocog alfa

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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