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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03196284
Other study ID # NN7415-4310
Secondary ID U1111-1179-29252
Status Completed
Phase Phase 2
First received
Last updated
Start date August 10, 2017
Est. completion date January 31, 2020

Study information

Verified date September 2021
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 26
Est. completion date January 31, 2020
Est. primary completion date September 19, 2018
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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
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

Locations

Country Name City State
Austria Novo Nordisk Investigational Site Wien
Canada Novo Nordisk Investigational Site Toronto Ontario
Croatia Novo Nordisk Investigational Site Zagreb
Denmark Novo Nordisk Investigational Site Århus N
Greece Novo Nordisk Investigational Site Athens
Israel Novo Nordisk Investigational Site Tel-Hashomer
Italy Novo Nordisk Investigational Site Firenze
Italy Novo Nordisk Investigational Site Milano
Japan Novo Nordisk Investigational Site Aichi
Japan Novo Nordisk Investigational Site Nara
Japan Novo Nordisk Investigational Site Tokyo
Malaysia Novo Nordisk Investigational Site Georgetown, Penang
Malaysia Novo Nordisk Investigational Site Kota Kinabalu
Spain Novo Nordisk Investigational Site Madrid
Spain Novo Nordisk Investigational Site Sevilla
Sweden Novo Nordisk Investigational Site Solna
Ukraine Novo Nordisk Investigational Site Lviv
United Kingdom Novo Nordisk Investigational Site London
United Kingdom Novo Nordisk Investigational Site Sheffield
United States Novo Nordisk Investigational Site Indianapolis Indiana
United States Novo Nordisk Investigational Site Iowa City Iowa
United States Novo Nordisk Investigational Site Los Angeles California

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Austria,  Canada,  Croatia,  Denmark,  Greece,  Israel,  Italy,  Japan,  Malaysia,  Spain,  Sweden,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Number of Bleeding Episodes The number of bleeding episodes that were treated during at least 24 weeks from treatment onset (week 0) are presented. During at least 24 weeks from treatment onset (week 0)
Secondary The Number of Bleeding Episodes The number of bleeding episodes that were treated during at least 76 weeks from treatment onset (week 0) are presented. This outcome measure is applicable for only 'Concizumab' treatment arm. During at least 76 weeks from treatment onset (week 0)
Secondary The Number of Spontaneous Bleeding Episodes 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 (week 0) are presented. The data is presented per the last dose level which the participants have reached at the time of assessment. During at least 24 weeks from treatment onset (week 0)
Secondary The Number of Spontaneous Bleeding Episodes 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 (week 0) are presented. The data is presented per the last dose level which the participants have reached at the time of assessment. During at least 76 weeks from treatment onset (week 0)
Secondary 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 the dose level which the participants have reached at the time of event. During at least 24 weeks from treatment onset (week 0)
Secondary 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 the dose level which the participants have reached at the time of event. During at least 76 weeks from treatment onset (week 0)
Secondary Number of Treatment-emergent Adverse Events (TEAEs) Within 24 Hours After Eptacog Alfa Administration 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 within 24 hours after eptacog alfa administration are presented. This outcome measure is applicable only for 'Eptacog alfa' treatment arm. Within 24 hours after eptacog alfa administration
Secondary 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. This outcome measure is applicable for only 'Concizumab' treatment arm. During at least 24 weeks from treatment onset (week 0)
Secondary 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. This outcome measure is applicable for only 'Concizumab' treatment arm. During at least 76 weeks from treatment onset (week 0)
Secondary Change in Fibrinogen Change in fibrinogen 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. During at least 24 weeks from treatment onset (week 0)
Secondary Change in Fibrinogen 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. During at least 76 weeks from treatment onset (week 0)
Secondary Change in D-dimer 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. During at least 24 weeks from treatment onset (week 0)
Secondary Change in D-dimer 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. During at least 76 weeks from treatment onset (week 0)
Secondary Change in Prothrombin Fragment 1 + 2 (F1 + 2) Change in F1 + 2 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. During at least 24 weeks from treatment onset (week 0)
Secondary Change in Prothrombin Fragment 1 + 2 (F1 + 2) Change in F1 + 2 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. During at least 76 weeks from treatment onset (week 0)
Secondary Change in Prothrombin Time (PT) Change in PT 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. During at least 24 weeks from treatment onset (week 0)
Secondary Change in Prothrombin Time (PT) 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. During at least 76 weeks from treatment onset (week 0)
Secondary Change in Activated Partial Thromboplastin Time (APTT) Change in APTT 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. During at least 24 weeks from treatment onset (week 0)
Secondary Change in Activated Partial Thromboplastin Time (APTT) 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. During at least 76 weeks from treatment onset (week 0)
Secondary Change in Anti-thrombin (AT) Change in AT 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. During at least 24 weeks from treatment onset (week 0)
Secondary Change in Anti-thrombin (AT) 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. After at least 76 weeks from treatment onset (week 0)
Secondary Concentration of Concizumab 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. Prior to the last dose administration at 24 weeks
Secondary Concentration of Concizumab Concentration of concizumab prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. Prior to the last dose administration after atleast 76 weeks
Secondary Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value 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. Prior to the last dose administration at 24 weeks
Secondary Free Tissue Factor Pathway Inhibitor (TFPI) Concentration Value Free TFPI concentration value prior to the last dose administration after atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. Prior to the last dose administration after atleast 76 weeks
Secondary Peak Thrombin Generation 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. Prior to the last dose administration at 24 weeks
Secondary Peak Thrombin Generation 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 atleast 76 weeks is presented. The data is presented per the last dose level which the participants have reached at the time of assessment. Prior to the last dose administration after atleast 76 weeks
Secondary Endogenous Thrombin Potential 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. Prior to the last dose administration at 24 weeks
Secondary Endogenous Thrombin Potential 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. Prior to the last dose administration after atleast 76 weeks
Secondary Thrombin Generation Velocity Index 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. Prior to the last dose administration at 24 weeks
Secondary Thrombin Generation Velocity Index 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. Prior to the last dose administration after atleast 76 weeks
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