Brief Title
Safety, Tolerability, and Pharmacokinetics Study of Turoctocog Alfa Pegol Injected Under the Skin in Patients With Haemophilia A
Official Title
Safety, Tolerability, and Pharmacokinetics Study of Single and Multiple Subcutaneous Doses of Turoctocog Alfa Pegol in Patients With Haemophilia A
Brief Summary
The trial is conducted in Asia, Europe and North America. The aim of the study is to evaluate
the safety of administration under the skin of turoctocog alfa pegol (SC N8-GP) in patients
with severe haemophilia A.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of adverse events
Secondary Outcome
Cmax
Condition
Congenital Bleeding Disorder
Intervention
turoctocog alfa pegol
Study Arms / Comparison Groups
N8-GP s.c.
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
50
Start Date
January 30, 2017
Completion Date
October 15, 2018
Primary Completion Date
October 15, 2018
Eligibility Criteria
Inclusion Criteria:
- Male, age above or equal to 18 years at the time of signing informed consent,(part A).
- Male, age above or equal to 12 years at the time of signing informed consent,(part B).
- Diagnosis of congenital haemophilia A based on medical records (FVIII activity <1%).
- History of more than 150 exposure days to any FVIII containing products.
Exclusion Criteria:
- Previous participation in this trial. Participation is defined as signed informed
consent.
(Patients who have completed part A are allowed to also participate in part B. If so, a
separate informed consent covering part B must be signed.)
- Immune compromised patients due to human immunodeficiency virus (HIV) infection
(defined as viral load greater than or equal to 400.000 copies/mL and/or cluster of
differentiation 4+ (CD4+) lymphocyte count less than or equal to 200/μL performed at
screening or defined by medical records no older than 6 months)
- Any history of FVIII inhibitors (defined by medical records within 8 years of
randomisation)
- Inhibitors to FVIII (greater than or equal to 0.6 Bethesda unit (BU)) at screening,
measured by Nijmegen modified Bethesda method at central laboratory.
Gender
Male
Ages
12 Years - N/A
Accepts Healthy Volunteers
No
Contacts
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Location Countries
Austria
Location Countries
Austria
Administrative Informations
NCT ID
NCT02994407
Organization ID
NN7170-4213
Secondary IDs
U1111-1183-5111
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
, ,
Verification Date
January 2020