A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6) (explorer™6)

November 22, 2021 updated by: Novo Nordisk A/S

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
231

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Algeria
      • Algiers, Algeria, 16000
        • Novo Nordisk Investigational Site
      • Constantine, Algeria, 25000
        • Novo Nordisk Investigational Site
  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3004
        • Novo Nordisk Investigational Site
      • Parkville, Victoria, Australia, 3052
        • Novo Nordisk Investigational Site
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Novo Nordisk Investigational Site
  • Austria
      • Amstetten, Austria, A 3300
        • Novo Nordisk Investigational Site
  • Bosnia and Herzegovina
      • Banja Luka, Bosnia and Herzegovina, 78000
        • Novo Nordisk Investigational Site
  • Bulgaria
      • Plovdiv, Bulgaria, 4002
        • Novo Nordisk Investigational Site
      • Sofia, Bulgaria, 1527
        • Novo Nordisk Investigational Site
      • Varna, Bulgaria, 9010
        • Novo Nordisk Investigational Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Novo Nordisk Investigational Site
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L4
        • Novo Nordisk Investigational Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B 3V6
        • Novo Nordisk Investigational Site
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • Novo Nordisk Investigational Site
      • Hamilton, Ontario, Canada, L8S 4K1
        • Novo Nordisk Investigational Site
  • Croatia
      • Zagreb, Croatia, 10 000
        • Novo Nordisk Investigational Site
      • Zagreb, Croatia, 10000
        • Novo Nordisk Investigational Site
  • Estonia
      • Tallinn, Estonia, 13419
        • Novo Nordisk Investigational Site
  • Finland
      • Helsinki, Finland, 00290
        • Novo Nordisk Investigational Site
  • France
      • Brest, France, 29609
        • Novo Nordisk Investigational Site
      • Bron Cedex, France, 69677
        • Novo Nordisk Investigational Site
      • Caen, France, 14033
        • Novo Nordisk Investigational Site
      • Kremlin-Bicêtre, France, 94270
        • Novo Nordisk Investigational Site
      • Lille, France, 59037
        • Novo Nordisk Investigational Site
      • Nantes Cedex 1, France, 44093
        • Novo Nordisk Investigational Site
      • Paris, France, 75015
        • Novo Nordisk Investigational Site
      • Rennes, France, 35033
        • Novo Nordisk Investigational Site
      • Saint Etienne, France, 42055
        • Novo Nordisk Investigational Site
  • Germany
      • Bonn, Germany, 53127
        • Novo Nordisk Investigational Site
      • Homburg, Germany, 66421
        • Novo Nordisk Investigational Site
  • Greece
      • Athens, Greece, GR-11527
        • Novo Nordisk Investigational Site
      • Thessaloniki, Greece, GR 54642
        • Novo Nordisk Investigational Site
  • Hungary
      • Budapest, Hungary, H-1134
        • Novo Nordisk Investigational Site
  • India
    • Karnataka
      • Bangalore, Karnataka, India, 560034
        • Novo Nordisk Investigational Site
    • Maharashtra
      • Pune, Maharashtra, India, 411004
        • Novo Nordisk Investigational Site
    • New Delhi
      • New Dehli, New Delhi, India, 110029
        • Novo Nordisk Investigational Site
    • Tamil Nadu
      • Vellore, Tamil Nadu, India, 632004
        • Novo Nordisk Investigational Site
    • West Bengal
      • Kolkatta, West Bengal, India, 70014
        • Novo Nordisk Investigational Site
  • Israel
      • Tel-Hashomer, Israel, 52621
        • Novo Nordisk Investigational Site
  • Italy
      • Castelfranco Veneto, Italy, 31033
        • Novo Nordisk Investigational Site
      • Firenze, Italy, 50134
        • Novo Nordisk Investigational Site
      • Roma, Italy, 00161
        • Novo Nordisk Investigational Site
      • Udine, Italy, 33100
        • Novo Nordisk Investigational Site
      • Verona, Italy, 37126
        • Novo Nordisk Investigational Site
  • Japan
      • Aichi, Japan, 466-8560
        • Novo Nordisk Investigational Site
      • Hiroshima, Japan, 734-8551
        • Novo Nordisk Investigational Site
      • Hyogo, Japan, 654-0047
        • Novo Nordisk Investigational Site
      • Kagoshima, Japan, 890-8760
        • Novo Nordisk Investigational Site
      • Kanagawa, Japan, 216-8511
        • Novo Nordisk Investigational Site
      • Kyoto, Japan, 602-8566
        • Novo Nordisk Investigational Site
      • Mie, Japan, 514-8507
        • Novo Nordisk Investigational Site
      • Nara, Japan, 634-8522
        • Novo Nordisk Investigational Site
      • Niigata, Japan, 941-8502
        • Novo Nordisk Investigational Site
      • Osaka, Japan, 546-0006
        • Novo Nordisk Investigational Site
      • Saitama, Japan, 330-8777
        • Novo Nordisk Investigational Site
      • Saitama, Japan, 350-0495
        • Novo Nordisk Investigational Site
      • Shizuoka, Japan, 420-8660
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 167-0035
        • Novo Nordisk Investigational Site
      • Tokyo, Japan, 157-8535
        • Novo Nordisk Investigational Site
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 361-711
        • Novo Nordisk Investigational Site
      • Daejeon, Korea, Republic of, 302-799
        • Novo Nordisk Investigational Site
      • Jeju-do, Korea, Republic of, 63241
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 03722
        • Novo Nordisk Investigational Site
      • Seoul, Korea, Republic of, 05278
        • Novo Nordisk Investigational Site
  • Lithuania
      • Vilnius, Lithuania, 08406
        • Novo Nordisk Investigational Site
      • Vilnius, Lithuania, LT-08661
        • Novo Nordisk Investigational Site
  • Malaysia
      • Selangor Darul Ehsan, Malaysia, 68000
        • Novo Nordisk Investigational Site
  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Novo Nordisk Investigational Site
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Novo Nordisk Investigational Site
  • Norway
      • Oslo, Norway, 0027
        • Novo Nordisk Investigational Site
  • Poland
      • Krakow, Poland, 31-501
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-081
        • Novo Nordisk Investigational Site
      • Lublin, Poland, 20-093
        • Novo Nordisk Investigational Site
      • Warszawa, Poland, 02-776
        • Novo Nordisk Investigational Site
  • Portugal
      • Porto, Portugal, 4200-319
        • Novo Nordisk Investigational Site
  • Russian Federation
      • Krasnodar, Russian Federation, 350007
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 119049
        • Novo Nordisk Investigational Site
      • Moscow, Russian Federation, 125167
        • Novo Nordisk Investigational Site
      • Saint-Petersburg, Russian Federation, 191186
        • Novo Nordisk Investigational Site
  • Serbia
      • Belgrade, Serbia, 11000
        • Novo Nordisk Investigational Site
      • Belgrade, Serbia, 11070
        • Novo Nordisk Investigational Site
      • Kragujevac, Serbia, 34000
        • Novo Nordisk Investigational Site
      • Novi Sad, Serbia, 21000
        • Novo Nordisk Investigational Site
  • Slovakia
      • Bratislava, Slovakia, 851 07
        • Novo Nordisk Investigational Site
  • South Africa
    • Gauteng
      • Parktown, Johannesburg, Gauteng, South Africa, 2193
        • Novo Nordisk Investigational Site
    • KwaZulu-Natal
      • Durban, KwaZulu-Natal, South Africa, 4013
        • Novo Nordisk Investigational Site
    • Limpopo
      • Polokwane, Limpopo, South Africa, 0699
        • Novo Nordisk Investigational Site
  • Spain
      • Madrid, Spain, 28046
        • Novo Nordisk Investigational Site
      • Málaga, Spain, 29010
        • Novo Nordisk Investigational Site
      • Oviedo, Spain, 33011
        • Novo Nordisk Investigational Site
      • Sevilla, Spain, 41013
        • Novo Nordisk Investigational Site
      • Valencia, Spain, 46026
        • Novo Nordisk Investigational Site
  • Sweden
      • Malmö, Sweden, 205 02
        • Novo Nordisk Investigational Site
      • Solna, Sweden, 171 64
        • Novo Nordisk Investigational Site
  • Switzerland
      • Zürich, Switzerland, 8091
        • Novo Nordisk Investigational Site
  • Turkey
      • Adana, Turkey, 01130
        • Novo Nordisk Investigational Site
      • Ankara, Turkey, 06230
        • Novo Nordisk Investigational Site
      • Ankara, Turkey, 06500
        • Novo Nordisk Investigational Site
      • Antalya, Turkey, 01010
        • Novo Nordisk Investigational Site
      • Bornova-IZMIR, Turkey, 35100
        • Novo Nordisk Investigational Site
      • Capa-ISTANBUL, Turkey, 35100
        • Novo Nordisk Investigational Site
      • Edirne, Turkey, 22030
        • Novo Nordisk Investigational Site
      • Istanbul, Turkey, 34098
        • Novo Nordisk Investigational Site
      • Samsun, Turkey
        • Novo Nordisk Investigational Site
  • Ukraine
      • Kyiv, Ukraine, 01135
        • Novo Nordisk Investigational Site
      • Lviv, Ukraine, 79044
        • Novo Nordisk Investigational Site
  • United Kingdom
      • Belfast, United Kingdom, BT9 7AB
        • Novo Nordisk Investigational Site
      • Birmingham, United Kingdom, B15 2TH
        • Novo Nordisk Investigational Site
      • London, United Kingdom, NW3 2QG
        • Novo Nordisk Investigational Site
      • London, United Kingdom, WC1N 3HR
        • Novo Nordisk Investigational Site
      • Manchester, United Kingdom, M13 9WL
        • Novo Nordisk Investigational Site
      • Nottingham, United Kingdom, NG7 2UH
        • Novo Nordisk Investigational Site
      • Sheffield, United Kingdom, S10 2JF
        • Novo Nordisk Investigational Site
  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Novo Nordisk Investigational Site
      • Sacramento, California, United States, 95817
        • Novo Nordisk Investigational Site
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Novo Nordisk Investigational Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Novo Nordisk Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Novo Nordisk Investigational Site
      • Augusta, Georgia, United States, 30912
        • Novo Nordisk Investigational Site
      • Macon, Georgia, United States, 31201
        • Novo Nordisk Investigational Site
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Novo Nordisk Investigational Site
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Novo Nordisk Investigational Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Novo Nordisk Investigational Site
      • East Lansing, Michigan, United States, 48823
        • Novo Nordisk Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Novo Nordisk Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89135
        • Novo Nordisk Investigational Site
    • New Jersey
      • Newark, New Jersey, United States, 07102
        • Novo Nordisk Investigational Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Novo Nordisk Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Novo Nordisk Investigational Site
      • Charlotte, North Carolina, United States, 28203
        • Novo Nordisk Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Novo Nordisk Investigational Site
      • Dayton, Ohio, United States, 45404
        • Novo Nordisk Investigational Site
    • Pennsylvania
      • Hershey, Pennsylvania, United States, 17033
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Novo Nordisk Investigational Site
      • Philadelphia, Pennsylvania, United States, 19134
        • Novo Nordisk Investigational Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Novo Nordisk Investigational Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232-9830
        • Novo Nordisk Investigational Site
    • Texas
      • Houston, Texas, United States, 77030
        • Novo Nordisk Investigational Site
      • San Antonio, Texas, United States, 78229
        • Novo Nordisk Investigational Site
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Novo Nordisk Investigational Site
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Novo Nordisk Investigational Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Patients with haemophilia A or B and with or without inhibitors

Description

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).

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Patients with haemophilia
Patients with haemophilia A or B and with or without inhibitors
Other: No treatment given
Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of treated bleeding episodes
Time Frame: From enrolment (week 0) and up to a maximum of 115 weeks
Count of treated bleeding episodes
From enrolment (week 0) and up to a maximum of 115 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The number of all bleeding episodes
Time Frame: From enrolment (week 0) and up to a maximum of 115 weeks
Count of bleeding episodes
From enrolment (week 0) and up to a maximum of 115 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novo Nordisk A/S

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 18, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 25, 2021

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 25, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 13, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 23, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NN7415-4322
  • U1111-1182-3359 (OTHER: World Health Organization (WHO))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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