Haemophilia A MedDRA version: 19.0 Level: LLT Classification code 10018938 Term: Haemophilia A (Factor VIII) System Organ Class: 100000004850
Conditions
Interventions
Product Name: N8-GP rFVIII
Product Code: NNC129-1003
Pharmaceutical Form: Powder and solvent for solution for injection
INN or Proposed INN: turoctocog alfa pegol
Current Sponsor code: NNC129-1003
Oth
Sponsors
Novo Nordisk A/S
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. 2. Ongoing participation in pathfinder™2 (NN7088-3859) 3. Male, age = 12 years at the time of signing informed consent (in certain countries the lower age limit will be 18 years, according to local requirements) Are the trial subjects under 18? yes Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 1
Exclusion criteria
Exclusion criteria: 1. FVIII inhibitors (=0.6 BU) at last visit in pathfinder™2 prior to entry in pathfinder™7 2. Planned surgery during the trial 3. Major surgery performed within 4 weeks prior to screening 4. Previous participation in this trial. Participation is defined as signed informed consent 5. Any disorder, except for conditions associated with haemophilia A, which in the investigator’s opinion might jeopardise patient’s safety or compliance with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate and compare the single-dose pharmacokinetic of turoctocog alfa pegol from the pivotal process with turoctocog alfa pegol from the commercial process, each given as intravenous administrations of 50 U/kg to patients with severe haemophilia A;Secondary Objective: To assess the safety of turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process after single intravenous doses of 50 U/kg in patients with severe haemophilia A;Primary end point(s): Area under the FVIII activity-time curve - dose normalised to 50 U/kg (AUC0-96h, norm);Timepoint(s) of evaluation of this end point: From 0 to 96 h post injection | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary pharmacokinetic endpoints are for the first and second pharmacokinetic periods, separately. The following pharmacokinetic endpoints will be derived based on plasma FVIII activity measured: 1. FVIII activity 30 min post administration - dose normalised to 50 U/kg 2. Area under the FVIII activity-time curve from 0 to infinity 3. Clearance 4. Incremental recovery 5. Terminal half-life All blood samples for the pharmacokinetic assessment will be analysed using both chromogenic and one-stage clotting assays. ;Timepoint(s) of evaluation of this end point: From time of trial product administration to 96 hours post-dose | — |
Countries
Denmark, European Union, France, Germany, Netherlands, Spain, United States
Contacts
Public ContactGlobal Clinical Registry (GCR,1452)
Novo Nordisk A/S
Outcome results
None listed