Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
MY TRIALS
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Register a trial
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04083781
Registration number
NCT04083781
Ethics application status
Date submitted
6/09/2019
Date registered
10/09/2019
Titles & IDs
Public title
Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia With Inhibitors
Query!
Scientific title
Efficacy and Safety of Concizumab Prophylaxis in Patients With Haemophilia A or B With Inhibitors
Query!
Secondary ID [1]
0
0
U1111-1225-9670
Query!
Secondary ID [2]
0
0
NN7415-4311
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
explorer7
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Haemophilia A With Inhibitors
0
0
Query!
Haemophilia B With Inhibitors
0
0
Query!
Condition category
Condition code
Blood
0
0
0
0
Query!
Clotting disorders
Query!
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Other human genetics and inherited disorders
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Concizumab
Experimental: Arm 1: No prophylaxis - Haemophilia A with inhibitors (HAwI) and haemophilia B with inhibitors (HBwI) patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis. In the extension part, patients in arm 1 will receive daily concizumab subcutaneous (s.c., under the skin) injections.
Experimental: Arm 2: Concizumab prophylaxis - HAwI and HBwI patients, previously treated on-demand, will be randomised 1:2 to no prophylaxis versus concizumab prophylaxis.
Experimental: Arm 3: Concizumab prophylaxis - The HAwI and HBwI patients enrolled into the concizumab phase 2 trial (NN7415-4310) at time of transfer will be offered enrolment into this trial. It is required that these patients are on concizumab prophylaxis up until enrolment into the trial. These patients will continue concizumab prophylaxis.
Experimental: Arm 4: Concizumab prophylaxis - Patients previously on prophylaxis with by-passing agents and on-demand patients who are screened at a timepoint where the required number of patients in arms 1 and 2 have been randomised. These patients will, if eligible, be enrolled into the trial and will initiate concizumab prophylaxis at visit 2a (week 0).
Treatment: Drugs: Concizumab
Concizumab will be administered daily subcutaneously (s.c., under the skin). When patients are randomised to concizumab prophylaxis they will receive a loading dose of 1.0 mg/kg concizumab at visit 2a (week 0: arm 2, 3 \& 4) or visit 9a (week 24: arm 1) followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week dose adjustment period on 0.20 mg/kg concizumab, the patients can be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab. A potential dose adjustment will take place at visit 4a.1 (week 6: arm 2, 3 \& 4) or 9a.3 (week 30: arm 1) and will be based on the concizumab exposure level measured at the previous visit 4a (week 4) or 9a.2 (week 28). Patients who have concizumab exposure levels of 200-4000 ng/mL will stay at 0.20 mg/kg concizumab. Patients in arm 1 will continue on-demand treatment with their usual bypassing product until visit 9a (week 24: end of main part for arm 1).
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
The number of treated spontaneous and traumatic bleeding episodes
Query!
Assessment method [1]
0
0
This will be presented as 'count of episodes'.
Query!
Timepoint [1]
0
0
On demand (arm 1): From randomisation (week 0) up until start of concizumab treatment (at least 24 weeks). Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)
Query!
Secondary outcome [1]
0
0
Change in 36 Item short form health survey version 2 (SF36v2) bodily pain
Query!
Assessment method [1]
0
0
This will be presented as 'score on a scale'. The bodily pain subscale of the SF-36v2 questionnaire consists of 2 items. Subscale scores range from 0-100 and are transformed into population norm adjusted T-scores. A higher score indicates a better outcome on this subscale.
Query!
Timepoint [1]
0
0
From start of treatment (week 0) until week 24. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Query!
Secondary outcome [2]
0
0
Change in SF36v2 physical functioning
Query!
Assessment method [2]
0
0
This will be presented as 'score on a scale'. The physical function subscale of the SF-36v2 questionnaire consists of 1 item with 10 subitems. Subscale scores range from 0-100 and are transformed into population norm adjusted T-scores. A higher score indicates a better outcome on this subscale.
Query!
Timepoint [2]
0
0
From start of treatment (week 0) until week 24. Week 0 is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Query!
Secondary outcome [3]
0
0
Number of treated spontaneous bleeding episodes
Query!
Assessment method [3]
0
0
This will be presented as 'count of episodes'.
Query!
Timepoint [3]
0
0
On demand (arm 1): From randomisation (week 0) up until start of concizumab treatment (at least 24 weeks) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)
Query!
Secondary outcome [4]
0
0
Number of treated spontaneous and traumatic joint bleeds
Query!
Assessment method [4]
0
0
This will be presented as 'count of episodes'.
Query!
Timepoint [4]
0
0
On demand (arm 1): From randomisation (week 0) up until start of concizumab treatment (at least 24 weeks) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)
Query!
Secondary outcome [5]
0
0
Number of treated spontaneous and traumatic target joint bleeds
Query!
Assessment method [5]
0
0
This will be presented as 'count of episodes'.
Query!
Timepoint [5]
0
0
On demand (arm 1): From randomisation (week 0) up until start of concizumab treatment (at least 24 weeks) Concizumab (arm 2): From start of the new concizumab dosing regimen (week 0) up until the primary analysis cut-off (at least 32 weeks)
Query!
Secondary outcome [6]
0
0
Number of thromboembolic events
Query!
Assessment method [6]
0
0
This will be presented as 'count of thromboembolic events'. On demand (arm 1 main part): From randomisation to on demand treatment up until start of concizumab treatment. Concizumab (arms 2-4): Before the pause: From start of concizumab treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment (week 0) up until the primary analysis cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of the new concizumab dosing regimen (week 25) up until the primary analysis cut-off. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day). Week 0, after the pause is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Query!
Timepoint [6]
0
0
Timeframe is presented under 'outcome measure description'
Query!
Secondary outcome [7]
0
0
Number of thromboembolic events
Query!
Assessment method [7]
0
0
This will be presented as 'count of thromboembolic events'. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day).
Query!
Timepoint [7]
0
0
Concizumab: Before the pause: From start of treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment up until the end of trial (up to 280 weeks).
Query!
Secondary outcome [8]
0
0
Number of hypersensitivity type reactions
Query!
Assessment method [8]
0
0
This will be presented as 'count of hypersensitivity type reactions'. On demand (arm 1 main part): From randomisation to on demand treatment up until start of concizumab treatment. Concizumab (arms 2-4): Before the pause: From start of concizumab treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment (week 0) up until the primary analysis cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of the new concizumab dosing regimen (week 25) up until the primary analysis cut-off. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day). Week 0, after the pause is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Query!
Timepoint [8]
0
0
Timeframe is presented under 'outcome measure description'
Query!
Secondary outcome [9]
0
0
Number of hypersensitivity type reactions
Query!
Assessment method [9]
0
0
This will be presented as 'count of hypersensitivity type reactions'. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day).
Query!
Timepoint [9]
0
0
Concizumab: Before the pause: From start of treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment up until the end of trial (up to 280 weeks).
Query!
Secondary outcome [10]
0
0
Number of injection site reactions
Query!
Assessment method [10]
0
0
This will be presented as 'count of injection site reactions'. On demand (arm 1 main part): From randomisation to on demand treatment up until start of concizumab treatment. Concizumab (arms 2-4): Before the pause: From start of concizumab treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment (week 0) up until the primary analysis cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of the new concizumab dosing regimen (week 25) up until the primary analysis cut-off. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day). Week 0, after the pause is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Query!
Timepoint [10]
0
0
Timeframe is presented under 'outcome measure description'
Query!
Secondary outcome [11]
0
0
Number of injection site reactions
Query!
Assessment method [11]
0
0
This will be presented as 'count of injection site reactions'. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day).
Query!
Timepoint [11]
0
0
Concizumab: Before the pause: From start of treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment up until the end of trial (up to 280 weeks).
Query!
Secondary outcome [12]
0
0
Number of patients with antibodies to concizumab
Query!
Assessment method [12]
0
0
This will be presented as 'count of patients'. Concizumab (arms 2-4): Before the pause: From start of concizumab treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment (week 0) up until the primary analysis cut-off (at least 32 weeks). Concizumab (arm 1 extension part): From start of the new concizumab dosing regimen (week 25) up until the primary analysis cut-off. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day). Week 0, after the pause is defined as time of randomisation to on-demand administration or time of start of the new concizumab dosing regimen.
Query!
Timepoint [12]
0
0
Timeframe is presented under 'outcome measure description'
Query!
Secondary outcome [13]
0
0
Number of patients with antibodies to concizumab
Query!
Assessment method [13]
0
0
This will be presented as 'count of patients'. Week 0, before the pause is defined as the time of randomisation to on-demand administration or time of start of the initial concizumab dosing regimen (0.25 mg/kg/day).
Query!
Timepoint [13]
0
0
Concizumab: Before the pause: From start of treatment (week 0) up until 7 weeks after the treatment was paused. After the pause: From start of concizumab treatment up until the end of trial (up to 280 weeks).
Query!
Secondary outcome [14]
0
0
Pre-dose (trough) concizumab plasma concentration (Ctrough)
Query!
Assessment method [14]
0
0
This will be measured in 'ng/mL'.
Query!
Timepoint [14]
0
0
Prior to the concizumab administration at week 24 (after restart)
Query!
Secondary outcome [15]
0
0
Pre-dose thrombin peak
Query!
Assessment method [15]
0
0
This will be measured in 'nmol/L'.
Query!
Timepoint [15]
0
0
Prior to the concizumab administration at week 24 (after restart)
Query!
Secondary outcome [16]
0
0
Pre-dose free tissue factor pathway inhibitor (TFPI) concentration
Query!
Assessment method [16]
0
0
This will be measured in 'ng/mL'.
Query!
Timepoint [16]
0
0
Prior to the concizumab administration at week 24 (after restart)
Query!
Secondary outcome [17]
0
0
Maximum concizumab plasma concentration (Cmax)
Query!
Assessment method [17]
0
0
This will be measured in 'ng/mL'.
Query!
Timepoint [17]
0
0
From 0 to 24 hours where 0 is time of the concizumab dose at week 24 (after restart)
Query!
Secondary outcome [18]
0
0
Area under the concizumab plasma concentration-time curve (AUC)
Query!
Assessment method [18]
0
0
This will be measured in 'ng\*hr/mL'.
Query!
Timepoint [18]
0
0
From 0 to 24 hours where 0 is time of the concizumab dose at week 24 (after restart)
Query!
Eligibility
Key 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 suitability for the trial.
* Male aged 12 years or older at the time of signing informed consent.
* Congenital Haemophilia A or B of any severity with documented history of inhibitor (equal to or above 0.6 Bethesda Units (BU).
* Patient has been prescribed, or in need of, treatment with bypassing agents in the last 24 weeks prior to screening (for patients not previously enrolled in NN7415-4310 (explorer 4)).
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Males
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Known or suspected hypersensitivity to any constituent of the trial product or related products.
* Known inherited or acquired coagulation disorder other than congenital haemophilia.
* Ongoing or planned Immune Tolerance Induction treatment.
* History of thromboembolic disease (includes arterial and venous thrombosis including myocardial infarction, pulmonary embolism, cerebral infarction/thrombosis, deep vein thrombosis, other clinically significant thromboembolic events and peripheral artery occlusion). Current clinical signs of, or treatment for thromboembolic disease. Patients who in the judgement of the investigator are considered at high risk of thromboembolic events (thromboembolic risk factors could include, but are not limited to, hypercholesterolemia, diabetes mellitus, hypertension, obesity, smoking, family history of thromboembolic events, arteriosclerosis, other conditions associated with increased risk of thromboembolic events.)
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Active, not recruiting
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
21/10/2019
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
31/12/2025
Query!
Actual
Query!
Sample size
Target
136
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
VIC,WA
Query!
Recruitment hospital [1]
0
0
The Alfred - Melbourne
Query!
Recruitment hospital [2]
0
0
Fiona Stanley Hospital - Haemophilia and Haemostasis Centre - Murdoch
Query!
Recruitment postcode(s) [1]
0
0
3004 - Melbourne
Query!
Recruitment postcode(s) [2]
0
0
6150 - Murdoch
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
California
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Georgia
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Indiana
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Missouri
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
North Carolina
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Tennessee
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Texas
Query!
Country [8]
0
0
Algeria
Query!
State/province [8]
0
0
Algiers
Query!
Country [9]
0
0
Algeria
Query!
State/province [9]
0
0
Constantine
Query!
Country [10]
0
0
Austria
Query!
State/province [10]
0
0
Wien
Query!
Country [11]
0
0
Bulgaria
Query!
State/province [11]
0
0
Sofia
Query!
Country [12]
0
0
Croatia
Query!
State/province [12]
0
0
Zagreb
Query!
Country [13]
0
0
Czechia
Query!
State/province [13]
0
0
Praha 2
Query!
Country [14]
0
0
Czechia
Query!
State/province [14]
0
0
Praha
Query!
Country [15]
0
0
Denmark
Query!
State/province [15]
0
0
Aarhus N
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Bron
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Clermont-Ferrand
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
Le Kremlin-Bicetre
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Rennes
Query!
Country [20]
0
0
India
Query!
State/province [20]
0
0
Karnataka
Query!
Country [21]
0
0
India
Query!
State/province [21]
0
0
Maharashtra
Query!
Country [22]
0
0
India
Query!
State/province [22]
0
0
New Delhi
Query!
Country [23]
0
0
India
Query!
State/province [23]
0
0
Tamil Nadu
Query!
Country [24]
0
0
Italy
Query!
State/province [24]
0
0
FI
Query!
Country [25]
0
0
Italy
Query!
State/province [25]
0
0
Castelfranco Veneto
Query!
Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Milano
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Udine
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Verona
Query!
Country [29]
0
0
Japan
Query!
State/province [29]
0
0
Aichi
Query!
Country [30]
0
0
Japan
Query!
State/province [30]
0
0
Kagoshima
Query!
Country [31]
0
0
Japan
Query!
State/province [31]
0
0
Kanagawa
Query!
Country [32]
0
0
Japan
Query!
State/province [32]
0
0
Nara
Query!
Country [33]
0
0
Japan
Query!
State/province [33]
0
0
Saitama
Query!
Country [34]
0
0
Japan
Query!
State/province [34]
0
0
Tokyo
Query!
Country [35]
0
0
Korea, Republic of
Query!
State/province [35]
0
0
Daejeon
Query!
Country [36]
0
0
Korea, Republic of
Query!
State/province [36]
0
0
Seoul
Query!
Country [37]
0
0
Malaysia
Query!
State/province [37]
0
0
Sabah
Query!
Country [38]
0
0
Malaysia
Query!
State/province [38]
0
0
Ampang, Selangor
Query!
Country [39]
0
0
Malaysia
Query!
State/province [39]
0
0
Georgetown, Penang
Query!
Country [40]
0
0
Mexico
Query!
State/province [40]
0
0
Nuevo León
Query!
Country [41]
0
0
Norway
Query!
State/province [41]
0
0
Oslo
Query!
Country [42]
0
0
Poland
Query!
State/province [42]
0
0
Mazowieckie
Query!
Country [43]
0
0
Poland
Query!
State/province [43]
0
0
Malopolskie
Query!
Country [44]
0
0
Poland
Query!
State/province [44]
0
0
Lublin
Query!
Country [45]
0
0
Poland
Query!
State/province [45]
0
0
Wroclaw
Query!
Country [46]
0
0
Portugal
Query!
State/province [46]
0
0
Porto
Query!
Country [47]
0
0
Russian Federation
Query!
State/province [47]
0
0
Krasnodar
Query!
Country [48]
0
0
Russian Federation
Query!
State/province [48]
0
0
Moscow
Query!
Country [49]
0
0
Russian Federation
Query!
State/province [49]
0
0
Petrozavodsk
Query!
Country [50]
0
0
Russian Federation
Query!
State/province [50]
0
0
Saint-Petersburg
Query!
Country [51]
0
0
Serbia
Query!
State/province [51]
0
0
Kragujevac
Query!
Country [52]
0
0
Slovakia
Query!
State/province [52]
0
0
Bratislava
Query!
Country [53]
0
0
South Africa
Query!
State/province [53]
0
0
Gauteng
Query!
Country [54]
0
0
South Africa
Query!
State/province [54]
0
0
KwaZulu-Natal
Query!
Country [55]
0
0
South Africa
Query!
State/province [55]
0
0
Limpopo
Query!
Country [56]
0
0
Spain
Query!
State/province [56]
0
0
Barcelona
Query!
Country [57]
0
0
Spain
Query!
State/province [57]
0
0
Madrid
Query!
Country [58]
0
0
Spain
Query!
State/province [58]
0
0
Málaga
Query!
Country [59]
0
0
Spain
Query!
State/province [59]
0
0
Oviedo
Query!
Country [60]
0
0
Spain
Query!
State/province [60]
0
0
Sevilla
Query!
Country [61]
0
0
Sweden
Query!
State/province [61]
0
0
Solna
Query!
Country [62]
0
0
Thailand
Query!
State/province [62]
0
0
Bangkok
Query!
Country [63]
0
0
Thailand
Query!
State/province [63]
0
0
Chiang Mai
Query!
Country [64]
0
0
Thailand
Query!
State/province [64]
0
0
Ubon Ratchathani
Query!
Country [65]
0
0
Turkey
Query!
State/province [65]
0
0
Adana
Query!
Country [66]
0
0
Turkey
Query!
State/province [66]
0
0
Antalya
Query!
Country [67]
0
0
Turkey
Query!
State/province [67]
0
0
Capa-ISTANBUL
Query!
Country [68]
0
0
Ukraine
Query!
State/province [68]
0
0
Kyiv
Query!
Country [69]
0
0
Ukraine
Query!
State/province [69]
0
0
Lviv
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Birmingham
Query!
Country [71]
0
0
United Kingdom
Query!
State/province [71]
0
0
London
Query!
Country [72]
0
0
United Kingdom
Query!
State/province [72]
0
0
Sheffield
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Novo Nordisk A/S
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This study will test how well a new medicine called concizumab works in the body of people with haemophilia A or B with inhibitors. The purpose is to show that concizumab can prevent bleeds in the body and is safe to use. Participants who usually only take medicine to treat bleeds (on-demand) will be placed in one of two groups. In one group, participants will get study medicine from the start of the study. In the other group, participants will continue with their normal medicine and get study medicine after 6 months. Which treatment the participant gets is decided by chance. Participants who usually take medicine to prevent bleeds (prophylaxis treatment) or who are already being treated with concizumab (study medicine) will receive the study medicine from the start of the study. Participants will get 1 injection with the study medicine every day under the skin. This participants will have to do themselves and can be done at home. The study doctor will hand out the medicine in the form of a pen-injector. The pen-injector will contain the study medicine. The study will last for about six years. The length of time the participants will be in the study depends on when they agreed to take part or when the medicine is available for purchase in their country (12 November 2025 at the latest). Participants will have to come to the clinic for up to 41 times. The time between visits will be approximately 4 weeks for the first 6 to 12 months, depending on the group participants are in and approximately 8 weeks for the rest of the study. Participants will be asked to record information into an electronic diary during the study and may also be asked to wear an activity tracker.
Query!
Trial website
https://clinicaltrials.gov/study/NCT04083781
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Reporting Anchor and Disclosure (1452)
Query!
Address
0
0
Novo Nordisk A/S
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
Query!
What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
Query!
When will data be available (start and end dates)?
Query!
Available to whom?
Query!
Available for what types of analyses?
Query!
How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com
Query!
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04083781