Safety, tolerability, and pharmacokinetics study of turoctocog alfa pegol injected under the skin in patients with haemophilia A
- Conditions
- Haemophilia AMedDRA version: 19.0Level: LLTClassification code 10018938Term: Haemophilia A (Factor VIII)System Organ Class: 100000004850Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
- Registration Number
- EUCTR2016-002396-99-DE
- Lead Sponsor
- ovo Nordisk A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 48
1. Male, age above or equal to 18 years at the time of signing informed consent,(part A).
2. Male, age above or equal to 12 years at the time of signing informed consent,(part B).
3. Diagnosis of congenital haemophilia A based on medical records (FVIII activity <1%).
4. History of more than 150 exposure days to any FVIII containing products.
Are the trial subjects under 18? yes
Number of subjects for this age range: 3
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 45
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. 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.)
2. Immune compromised patients due to human immunodeficiency virus (HIV) infection (defined as viral load =400.000 copies/mL and/or cluster of differentiation 4+ (CD4+) lymphocyte count =200/µL performed at screening or defined by medical records no older than 6 months)
3. Any history of FVIII inhibitors (defined by medical records within 8 years of randomisation)
4. Inhibitors to FVIII (= 0.6 Bethesda unit (BU)) at screening, measured by Nijmegen modified Bethesda method at central laboratory.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the safety of s.c. administration of turoctocog alfa pegol (SC N8-GP) in patients with severe haemophilia A;Secondary Objective: Not applicable;Primary end point(s): Number of adverse events reported after exposure to SC N8-GP ;Timepoint(s) of evaluation of this end point: Until 28 days after last exposure
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Pharmacokinetic parameter Cmax (up to 144 hours after dose) ;Timepoint(s) of evaluation of this end point: After single dose administration (part A)