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Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors

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NCT04082429 · results posted

Sponsored by Novo Nordisk A/S (industry) · NVO — their whole pipeline →.

Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
156actual
Sites
113
Countries
Algeria, Australia, Bosnia and Herzegovina +30

Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →

Source: ClinicalTrials.gov, retrieved 2026-08-19

Dates

each axis at the precision it was filed, with the registry's own basis
DateFiledBasisWhat it is
Start2019-11-13actualWhen the study began enrolling
Primary completion2022-07-12actualThe date the last participant is measured for the primary outcome — the readout window
Study completion2028-02-21estimatedThe whole study's end, after follow-up
First posted2019-09-09actualWhen this record first appeared on the registry
Results posted2025-10-31actualWhen the sponsor posted results to the registry
Record updated2026-08-13actualThe sponsor's own last edit to this record — every projection above is as current as this date

What it studies

Conditions

  • Haemophilia A Without Inhibitors
  • Haemophilia B Without Inhibitors

Intervention

  • Drug: Concizumab

Primary outcomes

what the primary-completion date above is the date OF
Haemophilia A Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes
measured On demand (arm 1): From week 0 up until start of concizumab treatment (week 24); Concizumab (arm 2): From week 0 up until the confirmatory analyses cut-off
Haemophilia B Participants Without Inhibitors: Rate of Treated Spontaneous and Traumatic Bleeding Episodes
measured On demand (arm 1): From week 0 up until start of concizumab treatment (week 24); Concizumab (arm 2): From week 0 up until the confirmatory analyses cut-off

Posted documents

hosted by the registry — we link, never re-serve
Study Protocolposted 2021-03-25 · 2.2 MB · Prot_000.pdf
Statistical Analysis Planposted 2022-08-04 · 509 KB · SAP_001.pdf

Publications

Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.

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