Clinical trial NCT01562587: Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non- Bleeding State
Official title: Pharmacokinetics of Single Bolus Dose of NovoSeven® in Paediatric and Adult Patients With Haemophilia A or B in a Non-Bleeding State
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Haemophilia B
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 18
Sex: MALE
Minimum age (years): 3
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this trial is to determine the pharmacokinetics of activated recombinant human factor VII (NovoSeven®) in haemophiliac patients in a non-bleeding state.


Eligibility criteria: Inclusion Criteria:

* Age 18-55 years and congenital haemophilia A or B male with severe FVIII or FX deficiency +/-inhibitors
* Age between 3-12 years and congenital haemophilia A or B male with record of inhibitors

Exclusion Criteria:

* Known hypersensitivity to activated recombinant human factor VII or any of its components
* Known clinical relevant coagulation diseases or insufficiencies other than congenital haemophilia
* Clinical manifestation of HIV (human immunodeficiency virus) and/or protease inhibitor treatment
* Clinical manifestation of active/recent bleeding
* Administration of coagulation factor preparations within 24 hours of NovoSeven trial product dose administration
* Body Mass Index (BMI) outside normal range
* Known abuse of elicit drugs and/or alcohol
* Renal insufficiency
* Hepatic disease
* Cardiovascular disease
* Any disease or condition which, judged by the Investigator, could imply a potential hazard to the patient, interfere with the trial participation or trial outcome

Primary outcomes:
measure: Area under the concentration curve from 0-12 hours
Secondary outcomes:
measure: CL, the total body clearance
measure: Cmax, the maximum concentration
measure: tmax, the time to maximum concentration
measure: t1/2, the terminal half-life
measure: Area under the concentration curve from time 0-infinity
measure: Vss, the apparent volume of distribution at steady state
measure: Adverse events
Other outcomes:
Locations:
city: Bremen
country: Germany
facility: Novo Nordisk Investigational Site
city: Frankfurt
country: Germany
facility: Novo Nordisk Investigational Site
city: Athens
country: Greece
facility: Novo Nordisk Investigational Site
city: Firenze
country: Italy
facility: Novo Nordisk Investigational Site
city: Milano
country: Italy
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Oxford
country: United Kingdom
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
citation: Villar A, Aronis S, Morfini M, Santagostino E, Auerswald G, Thomsen HF, Erhardtsen E, Giangrande PL. Pharmacokinetics of activated recombinant coagulation factor VII (NovoSeven) in children vs. adults with haemophilia A. Haemophilia. 2004 Jul;10(4):352-9. doi: 10.1111/j.1365-2516.2004.00925.x.