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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT02490787 |
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Date of registration:
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02/07/2015 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Trial Investigating Safety, Pharmacokinetics and Pharmacodynamics of Concizumab Administered Subcutaneously to Haemophilia A Subjects
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Scientific title:
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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) |
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Date of first enrolment:
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September 10, 2015 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02490787 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Austria
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Croatia
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France
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Germany
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Israel
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Malaysia
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Netherlands
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Poland
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Spain
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Thailand
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Global Clinical Registry (GCR, 1452) |
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Address:
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Telephone:
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Email:
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Affiliation:
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Novo Nordisk A/S |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
64 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Congenital Bleeding Disorder
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Haemophilia A
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Intervention(s)
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Drug: Concizumab
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Drug: placebo
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Primary Outcome(s)
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Number of adverse events (AEs)
[Time Frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration]
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Secondary Outcome(s)
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Frequency of binding non-neutralizing anti-concizumab antibodies
[Time Frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration]
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Trough level of concizumab
[Time Frame: Prior to the last s.c. dose administration (day 42)]
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Secondary ID(s)
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NL53826.018.15
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U1111-1161-1501
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NN7415-4159
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2014-003793-16
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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