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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
Date last updated
23/11/2021

Titles & IDs
Public title
A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)
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)
Secondary ID [1] 0 0
U1111-1182-3359
Secondary ID [2] 0 0
NN7415-4322
Universal Trial Number (UTN)
Trial acronym
explorer™6
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Haemophilia A 0 0
Haemophilia A With Inhibitors 0 0
Haemophilia B 0 0
Haemophilia B With Inhibitors 0 0
Condition category
Condition code
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The number of treated bleeding episodes
Timepoint [1] 0 0
From enrolment (week 0) and up to a maximum of 115 weeks
Secondary outcome [1] 0 0
The number of all bleeding episodes
Timepoint [1] 0 0
From enrolment (week 0) and up to a maximum of 115 weeks

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).
Minimum age
12 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
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.

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
18/12/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
25/10/2021
Sample size
Target
Accrual to date
Final
231
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Novo Nordisk Investigational Site - Melbourne
Recruitment hospital [2] 0 0
Novo Nordisk Investigational Site - Parkville
Recruitment hospital [3] 0 0
Novo Nordisk Investigational Site - Murdoch
Recruitment postcode(s) [1] 0 0
3004 - Melbourne
Recruitment postcode(s) [2] 0 0
3052 - Parkville
Recruitment postcode(s) [3] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
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United States of America
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Colorado
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District of Columbia
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Georgia
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Illinois
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Indiana
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Michigan
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Missouri
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Nevada
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New Jersey
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New Mexico
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North Carolina
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Virginia
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Wisconsin
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Algeria
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Algiers
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Algeria
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Constantine
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Austria
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Amstetten
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Bosnia and Herzegovina
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Banja Luka
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Varna
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Canada
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Alberta
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Canada
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New Brunswick
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Canada
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Newfoundland and Labrador
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Canada
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Ontario
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Croatia
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Zagreb
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Estonia
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Tallinn
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Finland
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Helsinki
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France
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Brest
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France
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Bron Cedex
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France
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Caen
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France
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Kremlin-Bicêtre
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France
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Lille
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France
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Nantes Cedex 1
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France
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Paris
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France
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Rennes
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France
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Saint Etienne
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Germany
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Bonn
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Germany
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Homburg
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Greece
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Athens
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Greece
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Thessaloniki
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Hungary
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Budapest
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India
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Karnataka
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India
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Maharashtra
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India
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New Delhi
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India
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Tamil Nadu
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India
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West Bengal
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Israel
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Tel-Hashomer
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Italy
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Castelfranco Veneto
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Italy
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Firenze
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Italy
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Roma
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Italy
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Udine
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Italy
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Verona
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Japan
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Aichi
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Japan
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Hiroshima
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Japan
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Hyogo
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Japan
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Kagoshima
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Japan
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Kanagawa
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Japan
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Kyoto
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Japan
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Mie
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Japan
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Nara
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Japan
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Niigata
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Japan
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Osaka
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Japan
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Saitama
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Japan
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Shizuoka
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Japan
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Tokyo
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Korea, Republic of
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Busan
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Korea, Republic of
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Daejeon
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Korea, Republic of
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Jeju-do
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Seoul
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Lithuania
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Vilnius
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Selangor Darul Ehsan
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Mexico
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Groningen
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Oslo
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Poland
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Krakow
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Poland
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Lublin
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Poland
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Warszawa
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Portugal
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Porto
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Russian Federation
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Krasnodar
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Russian Federation
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Moscow
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Russian Federation
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Saint-Petersburg
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Serbia
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Belgrade
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Serbia
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Kragujevac
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Serbia
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Novi Sad
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Slovakia
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Bratislava
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South Africa
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Gauteng
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South Africa
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KwaZulu-Natal
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South Africa
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Limpopo
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Spain
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Madrid
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Spain
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Málaga
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Spain
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Oviedo
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Spain
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Sevilla
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Spain
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Valencia
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Sweden
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Malmö
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Sweden
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Solna
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Switzerland
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Zürich
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Antalya
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Turkey
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Bornova-IZMIR
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Turkey
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Capa-ISTANBUL
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Turkey
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Edirne
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Turkey
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Istanbul
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Turkey
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Samsun
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Ukraine
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Kyiv
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Ukraine
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Lviv
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United Kingdom
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Belfast
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United Kingdom
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Birmingham
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Nottingham
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United Kingdom
State/province [119] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novo Nordisk A/S
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT03741881
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Reporting Anchor and Disclosure (1452)
Address 0 0
Novo Nordisk A/S
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03741881