Clinical trial NCT02490787: Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
Official title: A Multi-centre, Randomised, Placebo Controlled, Double Blinded, Multiple Dose Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects (Explorer™3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Congenital Bleeding Disorder
Haemophilia A
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2015-07-07
Enrollment: 24
Sex: MALE
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This trial is conducted globally. The aim of this trial is to investigate safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of concizumab administered subcutaneously to haemophilia A subjects.


Eligibility criteria: Inclusion Criteria:

* Male subjects diagnosed with haemophilia A without inhibitors present at screening and currently treated on-demand
* Subjects with a baseline level of factor VIII below or equal to 2 % based on medical records
* Age between 18 and 64 years both inclusive, at the time of signing informed consent
* Body weight between 50 and 100 kg, both inclusive

Exclusion Criteria:

* Known or suspected hypersensitivity to trial product or related products
* Platelet count below 50x10\^9/L at screening
* Any clinical signs or known history of thromboembolic events, or subjects considered at high risk of thromboembolic events as judged by the investigator
* Subjects at increased risk of cardiovascular disease as judged by the investigator

Primary outcomes:
measure: Number of adverse events (AEs)
timeFrame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
Secondary outcomes:
measure: Trough level of concizumab
timeFrame: Prior to the last s.c. dose administration (day 42)
measure: Frequency of binding non-neutralizing anti-concizumab antibodies
timeFrame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Novo Nordisk Investigational Site
state: California
city: Indianapolis
country: United States
facility: Novo Nordisk Investigational Site
state: Indiana
city: Iowa City
country: United States
facility: Novo Nordisk Investigational Site
state: Iowa
city: Baltimore
country: United States
facility: Novo Nordisk Investigational Site
state: Maryland
city: New York
country: United States
facility: Novo Nordisk Investigational Site
state: New York
city: Portland
country: United States
facility: Novo Nordisk Investigational Site
state: Oregon
city: Houston
country: United States
facility: Novo Nordisk Investigational Site
state: Texas
city: Milwaukee
country: United States
facility: Novo Nordisk Investigational Site
state: Wisconsin
city: Camperdown
country: Australia
facility: Novo Nordisk Investigational Site
state: New South Wales
city: Melbourne
country: Australia
facility: Novo Nordisk Investigational Site
state: Victoria
city: Wien
country: Austria
facility: Novo Nordisk Investigational Site
city: Zagreb
country: Croatia
facility: Novo Nordisk Investigational Site
city: Bron Cedex
country: France
facility: Novo Nordisk Investigational Site
city: Nantes Cedex 1
country: France
facility: Novo Nordisk Investigational Site
city: Rennes
country: France
facility: Novo Nordisk Investigational Site
city: Berlin
country: Germany
facility: Novo Nordisk Investigational Site
city: Duisburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Homburg
country: Germany
facility: Novo Nordisk Investigational Site
city: Tel-Hashomer
country: Israel
facility: Novo Nordisk Investigational Site
city: Kuala Lumpur
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Kuching
country: Malaysia
facility: Novo Nordisk Investigational Site
city: Amsterdam
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Nijmegen
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Utrecht
country: Netherlands
facility: Novo Nordisk Investigational Site
city: Warszawa
country: Poland
facility: Novo Nordisk Investigational Site
city: Madrid
country: Spain
facility: Novo Nordisk Investigational Site
city: Bangkok
country: Thailand
facility: Novo Nordisk Investigational Site
city: Bornova-IZMIR
country: Turkey
facility: Novo Nordisk Investigational Site
city: Dnipropetrovsk
country: Ukraine
facility: Novo Nordisk Investigational Site
city: Lviv
country: Ukraine
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: London
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Sheffield
country: United Kingdom
facility: Novo Nordisk Investigational Site
city: Southampton
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: