Brief Title
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
Official Title
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
Brief 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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
Number of Participants With Inhibitory Antibodies Against Coagulation Factor VIII (FVIII) ≥0.6 Bethesda Units
Secondary Outcome
Frequency of Adverse Events Including Serious Adverse Events Reported During the Trial Period
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa pegol
Study Arms / Comparison Groups
N8-GP
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
68
Start Date
February 20, 2013
Completion Date
September 28, 2018
Primary Completion Date
September 15, 2014
Eligibility 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
Gender
Male
Ages
N/A - 11 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT01731600
Organization ID
NN7088-3885
Secondary IDs
U1111-1129-6009
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
November 2020