Brief Title
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)
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Number of adverse events (AEs)
Secondary Outcome
Trough level of concizumab
Condition
Congenital Bleeding Disorder
Intervention
Concizumab
Study Arms / Comparison Groups
Concizumab
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
24
Start Date
September 10, 2015
Completion Date
October 14, 2016
Primary Completion Date
October 14, 2016
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
Gender
Male
Ages
18 Years - 64 Years
Accepts Healthy Volunteers
No
Contacts
Global Clinical Registry (GCR, 1452), ,
Location Countries
Australia
Location Countries
Australia
Administrative Informations
NCT ID
NCT02490787
Organization ID
NN7415-4159
Secondary IDs
2014-003793-16
Responsible Party
Sponsor
Study Sponsor
Novo Nordisk A/S
Study Sponsor
Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S
Verification Date
July 2017