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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02490787




Registration number
NCT02490787
Ethics application status
Date submitted
2/07/2015
Date registered
7/07/2015
Date last updated
21/07/2017

Titles & IDs
Public title
Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
Scientific 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)
Secondary ID [1] 0 0
2014-003793-16
Secondary ID [2] 0 0
NN7415-4159
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Congenital Bleeding Disorder 0 0
Haemophilia A 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Concizumab
Treatment: Drugs - placebo

Experimental: Concizumab -

Placebo Comparator: Placebo -


Treatment: Drugs: Concizumab
Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)

Treatment: Drugs: placebo
Administered subcutaneously (s.c., under the skin)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of adverse events (AEs)
Timepoint [1] 0 0
From first trial drug administration (day 1) to 11 weeks after the first trial product administration
Secondary outcome [1] 0 0
Trough level of concizumab
Timepoint [1] 0 0
Prior to the last s.c. dose administration (day 42)
Secondary outcome [2] 0 0
Frequency of binding non-neutralizing anti-concizumab antibodies
Timepoint [2] 0 0
From first trial drug administration (day 1) to 11 weeks after the first trial product administration

Eligibility
Key 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
Minimum age
18 Years
Maximum age
64 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/09/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
14/10/2016
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3004 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Indiana
Country [3] 0 0
United States of America
State/province [3] 0 0
Iowa
Country [4] 0 0
United States of America
State/province [4] 0 0
Maryland
Country [5] 0 0
United States of America
State/province [5] 0 0
New York
Country [6] 0 0
United States of America
State/province [6] 0 0
Oregon
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Austria
State/province [9] 0 0
Wien
Country [10] 0 0
Croatia
State/province [10] 0 0
Zagreb
Country [11] 0 0
France
State/province [11] 0 0
Bron Cedex
Country [12] 0 0
France
State/province [12] 0 0
Nantes Cedex 1
Country [13] 0 0
France
State/province [13] 0 0
Rennes
Country [14] 0 0
Germany
State/province [14] 0 0
Berlin
Country [15] 0 0
Germany
State/province [15] 0 0
Duisburg
Country [16] 0 0
Germany
State/province [16] 0 0
Homburg
Country [17] 0 0
Israel
State/province [17] 0 0
Tel-Hashomer
Country [18] 0 0
Malaysia
State/province [18] 0 0
Kuala Lumpur
Country [19] 0 0
Malaysia
State/province [19] 0 0
Kuching
Country [20] 0 0
Netherlands
State/province [20] 0 0
Amsterdam
Country [21] 0 0
Netherlands
State/province [21] 0 0
Nijmegen
Country [22] 0 0
Netherlands
State/province [22] 0 0
Utrecht
Country [23] 0 0
Poland
State/province [23] 0 0
Warszawa
Country [24] 0 0
Spain
State/province [24] 0 0
Madrid
Country [25] 0 0
Thailand
State/province [25] 0 0
Bangkok
Country [26] 0 0
Turkey
State/province [26] 0 0
Bornova-IZMIR
Country [27] 0 0
Ukraine
State/province [27] 0 0
Dnipropetrovsk
Country [28] 0 0
Ukraine
State/province [28] 0 0
Lviv
Country [29] 0 0
United Kingdom
State/province [29] 0 0
London
Country [30] 0 0
United Kingdom
State/province [30] 0 0
Sheffield
Country [31] 0 0
United Kingdom
State/province [31] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT02490787
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Registry (GCR, 1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries