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

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 evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03741881
Recruitment Status : Enrolling by invitation
First Posted : November 15, 2018
Last Update Posted : July 24, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Description
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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.

Condition or disease Intervention/treatment
Haemophilia A Haemophilia A With Inhibitors Haemophilia B Haemophilia B With Inhibitors Other: No treatment given

Study Design
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Study Type : Observational
Estimated Enrollment : 230 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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)
Actual Study Start Date : December 18, 2018
Estimated Primary Completion Date : March 17, 2021
Estimated Study Completion Date : March 17, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Groups and Cohorts
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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).


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. The number of all bleeding episodes [ Time Frame: From enrolment (week 0) and up to a maximum of 115 weeks ]
    Count of bleeding episodes


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with haemophilia A or B and with or without inhibitors
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03741881


Locations
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Sponsors and Collaborators
Novo Nordisk A/S
Investigators
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Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
More Information
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Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT03741881    
Other Study ID Numbers: NN7415-4322
U1111-1182-3359 ( Other Identifier: World Health Organization (WHO) )
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: July 24, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com
URL: http://novonordisk-trials.com

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Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
 Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked