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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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
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
The Number of Bleeding Episodes During at Least 24 Weeks From Treatment Onset
The number of bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
Time frame: During at least 24 weeks from treatment onset
The Number of Bleeding Episodes During at Least 76 Weeks From Treatment Onset
The number of bleeding episodes that were treated during at least 76 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
Time frame: During at least 76 weeks from treatment onset
The Number of Spontaneous Bleeding Episodes During at Least 24 Weeks From Treatment Onset
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 24 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
Time frame: During at least 24 weeks from treatment onset
The Number of Spontaneous Bleeding Episodes During at Least 76 Weeks From Treatment Onset
Bleeds that were not linked to a specific, known action or event are called spontaneous bleeding episodes. The number of spontaneous bleeding episodes that were treated during at least 76 weeks from treatment onset are presented. The data is presented while on last dose level when the bleed occurred.
Time frame: During at least 76 weeks from treatment onset
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 24 Weeks From Treatment Onset
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 24 weeks from treatment onset (week 0) are presented. The data is presented per dose level participants were on at the time of onset of the adverse event.
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Novo Nordisk Investigational Site
Los Angeles, California, United States
Novo Nordisk Investigational Site
Indianapolis, Indiana, United States
Novo Nordisk Investigational Site
Oklahoma City, Oklahoma, United States
Novo Nordisk Investigational Site
Nashville, Tennessee, United States
Novo Nordisk Investigational Site
Salt Lake City, Utah, United States
Novo Nordisk Investigational Site
Brest, France
Novo Nordisk Investigational Site
Caen, France
Novo Nordisk Investigational Site
Nantes, France
Novo Nordisk Investigational Site
Bonn, Germany
Novo Nordisk Investigational Site
Homburg, Germany
...and 21 more locations
Time frame: During at least 24 weeks from treatment onset (week 0)
Number of Treatment-emergent Adverse Events (TEAEs) During at Least 76 Weeks From Treatment Onset
An adverse event (AE) was any untoward medical occurrence in a participant administered a medicinal product, and which does not necessarily had a causal relationship with this treatment. A TEAE was defined as an event that had onset from the first exposure to treatment until the last visit in the trial. Number of TEAEs that occurred during at least 76 weeks from treatment onset (week 0) are presented. The data is presented per dose level participants were on at the time of onset of the adverse event.
Time frame: During at least 76 weeks from treatment onset (week 0)
Occurrence of Anti-concizumab Antibodies During at Least 24 Weeks From Treatment Onset
Occurrence of anti-concizumab antibodies during at least 24 weeks from treatment onset (week 0) is presented. In the reported data, 'Yes' infers number of participants who showed positive anti-concizumab antibody tests whereas 'No' infers number of participants who showed negative anti-concizumab antibody tests.
Time frame: During at least 24 weeks from treatment onset (week 0)
Occurrence of Anti-concizumab Antibodies During at Least 76 Weeks From Treatment Onset
Occurrence of anti-concizumab antibodies during at least 76 weeks from treatment onset (week 0) is presented. In the reported data, 'Yes' infers number of participants who showed positive anti-concizumab antibody tests whereas 'No' infers number of participants who showed negative anti-concizumab antibody tests.
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Fibrinogen During 24 Weeks From Treatment Onset
Change in fibrinogen during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During 24 weeks from treatment onset (week 0)
Change in Fibrinogen During at Least 76 Weeks From Treatment Onset
Change in fibrinogen during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in D-dimer During 24 Weeks From Treatment Onset
Change in D-dimer during at least 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During 24 weeks from treatment onset (week 0)
Change in D-dimer During at Least 76 Weeks From Treatment Onset
Change in D-dimer during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Prothrombin Fragment 1 + 2 (F1 + F2) During 24 Weeks From Treatment Onset
Change in F1 + F2 during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During 24 weeks from treatment onset (week 0)
Change in Prothrombin Fragment 1 + 2 (F1 + F2) During at Least 76 Weeks From Treatment Onset
Change in F1 + F2 during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Prothrombin Time (PT) During 24 Weeks From Treatment Onset
Change in PT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During 24 weeks from treatment onset (week 0)
Change in Prothrombin Time (PT) During at Least 76 Weeks From Treatment Onset
Change in PT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Activated Partial Thromboplastin Time (APTT) During 24 Weeks From Treatment Onset
Change in APTT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During 24 weeks from treatment onset (week 0)
Change in Activated Partial Thromboplastin Time (APTT) During at Least 76 Weeks From Treatment Onset
Change in APTT during at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During at least 76 weeks from treatment onset (week 0)
Change in Anti-thrombin (AT) During 24 Weeks From Treatment Onset
Change in AT during 24 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During 24 weeks from treatment onset (week 0)
Change in Anti-thrombin (AT) After at Least 76 Weeks From Treatment
Change in AT after at least 76 weeks from treatment onset (week 0) is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: During at least 76 weeks from treatment onset (week 0)
Concentration of Concizumab Prior to the Last Dose Administration at 24 Weeks
Concentration of concizumab prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration at 24 weeks
Concentration of Concizumab Prior to the Last Dose Administration After at Least 76 Weeks
Concentration of concizumab prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration after at least 76 weeks
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration at 24 Weeks
Free TFPI (TFPI not bound to concizumab) concentration value prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration at 24 weeks
Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Prior to the Last Dose Administration After at Least 76 Weeks
Free TFPI concentration value prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration after at least 76 weeks
Peak Thrombin Generation Prior to the Last Dose Administration at 24 Weeks
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration at 24 weeks
Peak Thrombin Generation Prior to the Last Dose Administration After at Least 76 Weeks
Peak thrombin generation is the maximal concentration of thrombin formed at a given point in time. Peak thrombin generation prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration after at least 76 weeks
Endogenous Thrombin Potential Prior to the Last Dose Administration at 24 Weeks
The endogenous thrombin potential (ETP), defined as the amount of thrombin which can be generated after the in vitro activation of coagulation with tissue factor as trigger and phospholipids as platelet substitute. Endogenous thrombin potential prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration at 24 weeks
Endogenous Thrombin Potential Prior to the Last Dose Administration After at Least 76 Weeks
The endogenous thrombin potential (ETP), defined as the amount of thrombin which can be generated after the in vitro activation of coagulation with tissue factor as trigger and phospholipids as platelet substitute. Endogenous thrombin potential prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration after at least 76 weeks
Thrombin Generation Velocity Index Prior to the Last Dose Administration at 24 Weeks
Thrombin generation velocity index represents the effective rate of thrombin generation between lag time and time to peak. Thrombin generation velocity index prior to the last dose administration at 24 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration at 24 weeks
Thrombin Generation Velocity Index Prior to the Last Dose Administration After at Least 76 Weeks
Thrombin generation velocity index represents the effective rate of thrombin generation between lag time and time to peak. Thrombin generation velocity index prior to the last dose administration after at least 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment.
Time frame: Prior to the last dose administration after at least 76 weeks