A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

Status:	Completed
Conditions:	Hematology
Therapuetic Areas:	Hematology
Healthy:	No
Age Range:	Any - 11
Updated:	10/12/2018
Start Date:	February 20, 2013
End Date:	September 28, 2018

This trial is conducted globally. The aim of the trial is to investigate safety, efficacy and
pharmacokinetics (the exposure of the trial drug in the body) of NNC 0129-0000-1003 (N8-GP)
in children with severe haemophilia A who have undergone treatment with previous factor VIII
(FVIII) products.

Inclusion Criteria:

- Male patients with severe congenital haemophilia A (FVIII activity level below 1%)

- Weight above or equal to 10 kg - Documented history of 150 exposure days (ED) to FVIII
products for patients aged 6-11 years and above 50 ED to FVIII products for patients
aged 0-5 years

Exclusion Criteria:

- Any history of FVIII inhibitors

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A Multinational, Open-Label, Non-Controlled Trial on Safety, Efficacy and Pharmacokinetics of NNC 0129-0000-1003 in Previously Treated Paediatric Patients With Severe Haemophilia A

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