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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT03741881
Registration number
NCT03741881
Ethics application status
Date submitted
13/11/2018
Date registered
15/11/2018
Titles & IDs
Public title
A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)
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Scientific title
A Prospective, Multi-national, Non-interventional Study in Haemophilia A and B Patients With or Without Inhibitors Treated According to Routine Clinical Treatment Practice (Explorer™6)
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Secondary ID [1]
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0
U1111-1182-3359
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Secondary ID [2]
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NN7415-4322
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Universal Trial Number (UTN)
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Trial acronym
explorer™6
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Haemophilia A
0
0
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Haemophilia A With Inhibitors
0
0
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Haemophilia B
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0
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Haemophilia B With Inhibitors
0
0
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Condition category
Condition code
Blood
0
0
0
0
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Clotting disorders
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Human Genetics and Inherited Disorders
0
0
0
0
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Other human genetics and inherited disorders
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - No treatment given
Patients with haemophilia - Patients with haemophilia A or B and with or without inhibitors
Other interventions: No treatment given
Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).
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Intervention code [1]
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0
Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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The number of treated bleeding episodes
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Assessment method [1]
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Count of treated bleeding episodes
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Timepoint [1]
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From enrolment (week 0) and up to a maximum of 115 weeks
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Secondary outcome [1]
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The number of all bleeding episodes
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Assessment method [1]
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Count of bleeding episodes
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Timepoint [1]
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From enrolment (week 0) and up to a maximum of 115 weeks
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Eligibility
Key inclusion criteria
1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine eligibility for the study.
2. Male, age equal to or above 12 years at the time of signing informed consent.
3. Patients with congenital haemophilia with inhibitors treated with FEIBA® prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1).
(For Turkey only: Patients with congenital haemophilia with inhibitors treated with by-passing agents prophylaxis: equal to or above 2 treated bleeding episodes within 24 weeks before screening (visit 1)).
4. Severe (FVIII activity below 1%) congenital haemophilia A or severe/moderate (FIX activity equal to or below 2%) congenital haemophilia B, or congenital haemophilia A or B of any severity, with a presence or history of inhibitor (equal to or above 0.6 Bethesda Unit (BU)), based on medical records
5. Patients with CHwI treated on-demand: equal to or above 6 treated (with bypassing agent) bleeding episodes within 24 weeks (or equal to or above 12 during 52 weeks) before screening (visit 1) and patients with severe congenital HA/HB treated on-demand: equal to or above 5 treated (with factor product) bleeding episodes within 24 weeks (or equal to or above 10 during 52 weeks) before screening (visit 1).
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Minimum age
12
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Known or suspected hypersensitivity to monoclonal antibodies.
2. Previous participation in this study. Participation is defined as signed informed consent.
3. Any disorder, except for conditions associated with congenital haemophilia, which in the physician's opinion might jeopardise patient's safety or compliance with the protocol.
4. Previous treatment with concizumab. Previous treatment is defined as two or more doses administered.
5. Planned FVIII/FIX Immune Tolerance Induction (ITI) regimens during the study.
6. Current or planned treatment with emicizumab.
7. Any known congenital or acquired coagulation disorder other than congenital haemophilia.
8. History of thromboembolic disease, current clinical signs of or treatment for thromboembolic disease, or at high risk of thromboembolic disease as judged by the investigator.
9. Presence or history of malignant neoplasm within 5 years prior to the day of screening.
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/12/2018
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/10/2021
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Sample size
Target
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Accrual to date
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Final
231
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Recruitment in Australia
Recruitment state(s)
VIC,WA
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Recruitment hospital [1]
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Novo Nordisk Investigational Site - Melbourne
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Novo Nordisk Investigational Site - Parkville
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Novo Nordisk Investigational Site - Murdoch
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3004 - Melbourne
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Recruitment postcode(s) [2]
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3052 - Parkville
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Recruitment postcode(s) [3]
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6150 - Murdoch
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Funding & Sponsors
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Commercial sector/industry
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Name
Novo Nordisk A/S
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Ethics approval
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Summary
Brief summary
This study will collect data on bleeds and data related to quality of life in people with severe congenital (a disease existing from birth) haemophilia A and B, with or without inhibitors. The aim for the study is to look at the number of bleeds when on usual treatment for haemophilia. Participants will be asked to keep an electronic diary to track the number of bleeds and the treatment of their bleeds. Participants will be asked to wear an activity tracker on their wrist to capture their level of activity every day for up to 12 weeks. While taking part in this study, participants will keep getting their usual treatment as given to them by their doctor. All study visits at the clinic are done in the same way as the participants are used to. In the time between the participants' visits to the clinic, the study staff at the clinic may call or email the participant. The study will last for about 2½ years.
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Trial website
https://clinicaltrials.gov/study/NCT03741881
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Contacts
Principal investigator
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Clinical Reporting Anchor and Disclosure (1452)
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Novo Nordisk A/S
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
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When will data be available (start and end dates)?
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Available to whom?
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: http://novonordisk-trials.com
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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/NCT03741881