Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT02490787