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Trial record 23 of 397 for:    bleeding episodes

A Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors (explorer™5)

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ClinicalTrials.gov Identifier: NCT03196297
Recruitment Status : Active, not recruiting
First Posted : June 22, 2017
Last Update Posted : June 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Brief Summary:
This trial is conducted in Asia, Europe and the United States of America (USA). 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 patients with severe haemophilia A without inhibitors.

Condition or disease Intervention/treatment Phase
Haemostasis Haemophilia A Drug: Concizumab Drug: Turoctocog alfa Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-Centre Trial Evaluating Efficacy and Safety of Prophylactic Administration of Concizumab in Patients With Severe Haemophilia A Without Inhibitors
Actual Study Start Date : August 16, 2017
Actual Primary Completion Date : June 22, 2018
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arm Intervention/treatment
Experimental: Concizumab
Daily administration of concizumab to both on-demand and prophylaxis patients
Drug: Concizumab
0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase

Drug: Turoctocog alfa
Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels




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

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

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

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

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

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

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

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

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

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

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

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

  18. Change in antithrombin (AT) [ Time Frame: During 24 weeks from treatment onset (week 0) ]
    Measured in %

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

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

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

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

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

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

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

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

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

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

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



Information from the National Library of Medicine

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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 patients aged 18 years or older at the time of signing informed consent, diagnosed with severe haemophilia A (FVIII activity below 1%), based on medical records or results at screening Exclusion Criteria: - Known or suspected hypersensitivity to trial product(s) or related products - Known inherited or acquired bleeding disorder other than haemophilia A - Presence of inhibitors (neutralising antibodies) to Factor VIII (equal to or above 0.6 Bethesda Units) at screening measured by the Nijmegen method

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): NCT03196297


  Show 31 Study Locations
Sponsors and Collaborators
Novo Nordisk A/S

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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03196297     History of Changes
Other Study ID Numbers: NN7415-4255
U1111-1179-3872 ( Other Identifier: World Health Organization (WHO) )
2016-000614-29 ( Registry Identifier: EudraCT )
JapicCTI-173682 ( Registry Identifier: JAPIC )
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk 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
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants