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

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

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
Intervention / Treatment
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

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

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

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)

December 18, 2018

Primary Completion (ACTUAL)

October 25, 2021

Study Completion (ACTUAL)

October 25, 2021

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

November 13, 2018

First Posted (ACTUAL)

November 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

November 23, 2021

Last Update Submitted That Met QC Criteria

November 22, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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