Research Study on How Well Concizumab Works for You if You Have Haemophilia A or B With or Without Inhibitors (Explorer10)

Open-label Study Investigating Efficacy, Safety and Pharmacokinetics of Concizumab Prophylaxis in Children Below 12 Years With Haemophilia A or B With or Without Inhibitors

  • Clinical Trial Information

    Trial Contact: Spinelli, Jennifer; Parker, Melanie; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D

  • IRB No: 21.206.12

    Protocol Abbrev: NN7415-4616

    Principal Investigator: Shveta Gupta, MD

    Phase: Drug: Phase III

    Age Group: Pediatric

    Secondary Protocol No: Explorer 10

    Treatment: Drug: Concizumab

    Therapies Involved: Medication ID: NCT05135559

  • Objective

    This study will test how well a new medicine called concizumab works for participants who have haemophilia A or B with or without inhibitors. The purpose is to show that concizumab can prevent bleeds and is safe to use.

  • Key Eligibility

    Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
    Sexes Eligible for Study: All
    Accepts Healthy Volunteers: No

    Diagnosis of congenital severe haemophilia A (FVIII below 1%) or moderate/severe congenital haemophilia B (FIX (coagulation factor IX) below or equal to 2%), or congenital haemophilia with inhibitors.