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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03196297
Recruitment Status : Completed
First Posted : June 22, 2017
Last Update Posted : June 11, 2020
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
Allocation: N/A
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
Actual Study Completion Date : June 3, 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


Locations
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United States, California
Novo Nordisk Investigational Site
Los Angeles, California, United States, 90027
United States, Indiana
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States, 46260
United States, Oklahoma
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States, 73104
United States, Tennessee
Novo Nordisk Investigational Site
Nashville, Tennessee, United States, 37232
United States, Utah
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States, 84113
France
Novo Nordisk Investigational Site
Brest, France, 29609
Novo Nordisk Investigational Site
Caen, France, 14033
Novo Nordisk Investigational Site
Nantes Cedex 1, France, 44093
Germany
Novo Nordisk Investigational Site
Bonn, Germany, 53127
Novo Nordisk Investigational Site
Homburg, Germany, 66421
Italy
Novo Nordisk Investigational Site
Milano, Italy, 20124
Novo Nordisk Investigational Site
Rome, Italy, 00168
Japan
Novo Nordisk Investigational Site
Aichi, Japan, 466-8560
Novo Nordisk Investigational Site
Nara, Japan, 634-8522
Novo Nordisk Investigational Site
Tokyo, Japan, 160-0023
Novo Nordisk Investigational Site
Tokyo, Japan, 167-0035
Spain
Novo Nordisk Investigational Site
Madrid, Spain, 28046
Novo Nordisk Investigational Site
Málaga, Spain, 29010
Novo Nordisk Investigational Site
Valencia, Spain, 46026
Sweden
Novo Nordisk Investigational Site
Malmö, Sweden, 205 02
Novo Nordisk Investigational Site
Solna, Sweden, 171 64
Thailand
Novo Nordisk Investigational Site
Bangkok, Thailand, 10400
Turkey
Novo Nordisk Investigational Site
Ankara, Turkey, 06100
Novo Nordisk Investigational Site
Bornova-IZMIR, Turkey, 35100
Novo Nordisk Investigational Site
Edirne, Turkey, 22030
Novo Nordisk Investigational Site
İstanbul, Turkey, 34098
Ukraine
Novo Nordisk Investigational Site
Lviv, Ukraine, 79044
United Kingdom
Novo Nordisk Investigational Site
Belfast, United Kingdom, BT9 7AB
Novo Nordisk Investigational Site
Cambridge, United Kingdom, CB2 0QQ
Novo Nordisk Investigational Site
London, United Kingdom, NW3 2QG
Novo Nordisk Investigational Site
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Novo Nordisk A/S
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03196297    
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 11, 2020
Last Verified: June 2020
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