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Trial record 10 of 397 for:    bleeding episodes

A Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors (explorer™4)

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ClinicalTrials.gov Identifier: NCT03196284
Recruitment Status : Active, not recruiting
First Posted : June 22, 2017
Last Update Posted : June 6, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Africa, Asia, Europe and North America. The aim of the trial is to assess the efficacy of concizumab administered s.c. (subcutaneously, under the skin) once daily in preventing bleeding episodes in haemophilia A and B patients with inhibitors.

Condition or disease Intervention/treatment Phase
Congenital Bleeding Disorder Haemophilia A With Inhibitors Haemophilia B With Inhibitors Drug: Concizumab Drug: Eptacog alfa Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Centre, Randomised, Open-Label, Controlled Trial Evaluating the Efficacy and Safety of Prophylactic Administration of Concizumab in Haemophilia A and B Patients With Inhibitors
Actual Study Start Date : August 10, 2017
Actual Primary Completion Date : September 19, 2018
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hemophilia

Arm Intervention/treatment
Experimental: Concizumab
Concizumab administered in both the main phase and extension phase, with eptacog alfa administered on-demand during bleeding episodes
Drug: Concizumab
A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase

Drug: Eptacog alfa
A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms

Active Comparator: Eptacog alfa and concizumab
Eptacog alfa administered on-demand during bleeding episodes as the only intervention during the main phase. Concizumab given in the extension phase
Drug: Concizumab
A loading dose of 0.5 mg/kg will be given as the first dose, followed by 0.15 mg/kg (with potential stepwise dose escalation to 0.25 mg/kg) administered daily s.c. (subcutaneously, under the skin). Treatment duration is 24 weeks in the main trial, and up to 52 weeks in the extension phase

Drug: Eptacog alfa
A single dose of 90 μg/kg eptacog alfa one week after dosing with concizumab. On-demand treatment during bleeding episodes in both treatment arms




Primary Outcome Measures :
  1. The number of bleeding episodes [ Time Frame: During at least 24 weeks from treatment onset (week 0) ]
    Count of episodes


Secondary Outcome Measures :
  1. The number of bleeding episodes [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Count of episodes

  2. The number of spontaneous bleeding episodes [ Time Frame: During at least 24 weeks from treatment onset (week 0) ]
    Count of episodes

  3. The number of spontaneous bleeding episodes [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Count of episodes

  4. Number of treatment-emergent adverse events (TEAEs) [ Time Frame: During at least 24 weeks from treatment onset (week 0) ]
    Count of events

  5. Number of TEAEs [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Count of events

  6. Number of TEAEs [ Time Frame: Within 24 hours after eptacog alfa administration ]
    Count of events

  7. Occurrence of anti-concizumab antibodies [ Time Frame: During at least 24 weeks from treatment onset (week 0) ]
    Count of events

  8. Occurrence of anti-concizumab antibodies [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Count of events

  9. Change in fibrinogen [ Time Frame: During 24 weeks from treatment onset (week 0) ]
    Measured in g/L

  10. Change in fibrinogen [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Measured in g/L

  11. Change in D-dimer [ Time Frame: During 24 weeks from treatment onset (week 0) ]
    Measured in ng/ml

  12. Change in D-dimer [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Measured in ng/ml

  13. Change in prothrombin fragment 1 + 2 (F1 + 2) [ Time Frame: During 24 weeks from treatment onset (week 0) ]
    Measured in pmol/L

  14. Change in F1 + 2 [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Measured in pmol/L

  15. Change in prothrombin time (PT) [ Time Frame: During 24 weeks from treatment onset (week 0) ]
    Measured in seconds

  16. Change in PT [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Measured in seconds

  17. Change in activated partial thromboplastin time (APTT) [ Time Frame: During 24 weeks from treatment onset (week 0) ]
    Measured in seconds

  18. Change in APTT [ Time Frame: During at least 76 weeks from treatment onset (week 0) ]
    Measured in seconds

  19. Change in anti-thrombin (AT) [ Time Frame: During 24 weeks from treatment onset (week 0) ]
    Measured in %

  20. Change in AT [ Time Frame: After at least 76 weeks from treatment onset (week 0) ]
    Measured in %

  21. Concentration of concizumab [ Time Frame: Prior to the last dose administration at 24 weeks ]
    Measured in ng/ml

  22. Concentration of concizumab [ Time Frame: Prior to the last dose administration after at least 76 weeks ]
    Measured in ng/ml

  23. Free TFPI concentration value [ Time Frame: Prior to the last dose administration at 24 weeks ]
    Measured in ng/ml

  24. Free TFPI concentration value [ Time Frame: Prior to the last dose administration after at least 76 weeks ]
    Measured in ng/ml

  25. Peak thrombin generation [ Time Frame: Prior to the last dose administration at 24 weeks ]
    Measured in nM

  26. Peak thrombin generation [ Time Frame: Prior to the last dose administration after at least 76 weeks ]
    Measured in nM

  27. Endogenous thrombin potential [ Time Frame: Prior to the last dose administration at 24 weeks ]
    Measured in nM x min

  28. Endogenous thrombin potential [ Time Frame: Prior to the last dose administration after at least 76 weeks ]
    Measured in nM x min

  29. Thrombin generation velocity index [ Time Frame: Prior to the last dose administration at 24 weeks ]
    Measured in nM/min

  30. Thrombin generation velocity index [ Time Frame: Prior to the last dose administration after at least 76 weeks ]
    Measured in nM/min



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria
Inclusion Criteria: - Informed consent obtained before any trial related activities. Trial related activities are any procedures that are carried out as part of the trial, including activities to determine the suitability for the trial - Male haemophilia A or B patients with inhibitors aged 18 years or older at the time of signing informed consent - Patients currently in need of treatment with bypassing agents Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia - Ongoing or planned immune tolerance induction therapy or prophylaxis with FVIII or FIX

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03196284


  Show 22 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03196284     History of Changes
Other Study ID Numbers: NN7415-4310
U1111-1179-2925 ( Other Identifier: World Health Organization (WHO) )
2016-000510-30 ( EudraCT Number )
JapicCTI-173681 ( Registry Identifier: JAPIC )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 6, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to disclosure commitment on novonordisk-trials.com

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders
Hemostatic Disorders
Blood Coagulation Disorders, Inherited
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Vascular Diseases
Cardiovascular Diseases
Factor VIII
Coagulants