Overview

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
Trial end date:
2018-09-28
Target enrollment:
0
Participant gender:
Male
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novo Nordisk A/S
Treatments:
Factor VIII
Criteria
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