A Phase 1 interventional study of Concizumab and placebo in Congenital Bleeding Disorder and Haemophilia A, sponsored by Novo Nordisk A/S. Completed at 34 sites in 15 countries. Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2017-07-21.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
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.
885 studies on the registry are indexed under Hemophilia A; 139 are open to participants now.
This study's enrollment of 24 is below the median of 27 across 523 interventional studies indexed under Hemophilia A.
Browse Hemophilia A studies →Novo Nordisk A/S is the lead sponsor of 1,400 studies on the registry; 102 are open to participants now.
Of its 204 completed or terminated interventional studies of FDA-regulated products, 98 (48%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Drug: Concizumab · Drug: placebo
Drug: placebo
Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)
Administered subcutaneously (s.c., under the skin)
Number of adverse events (AEs)
Time frame: From first trial drug administration (day 1) to 11 weeks after the first trial product administration
Trough level of concizumab
Time frame: Prior to the last s.c. dose administration (day 42)
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
This study is completed, as verified in Jul 2017. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Concizumab