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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 : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Tracking Information
First Submitted Date November 13, 2018
First Posted Date November 15, 2018
Last Update Posted Date September 17, 2020
Actual Study Start Date December 18, 2018
Estimated Primary Completion Date March 17, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 22, 2020)
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
Original Primary Outcome Measures
 (submitted: November 13, 2018)
The number of treated bleeding episodes [ Time Frame: From enrolment (week 0) and up to a maximum of 89 weeks ]
Count of treated bleeding episodes
Change History
Current Secondary Outcome Measures
 (submitted: July 22, 2020)
The number of all bleeding episodes [ Time Frame: From enrolment (week 0) and up to a maximum of 115 weeks ]
Count of bleeding episodes
Original Secondary Outcome Measures
 (submitted: November 13, 2018)
The number of all bleeding episodes [ Time Frame: From enrolment (week 0) and up to a maximum of 89 weeks ]
Count of bleeding episodes
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study Following People With Haemophilia A and B, With or Without Inhibitors, When on Usual Treatment (Explorer™6)
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)
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with haemophilia A or B and with or without inhibitors
Condition
  • Haemophilia A
  • Haemophilia A With Inhibitors
  • Haemophilia B
  • Haemophilia B With Inhibitors
Intervention Other: No treatment given
Participants are treated with their usual prescribed treatment, either given regularly as a prevention (prophylaxis) or when needed (on-demand).
Study Groups/Cohorts Patients with haemophilia
Patients with haemophilia A or B and with or without inhibitors
Intervention: Other: No treatment given
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Enrolling by invitation
Estimated Enrollment
 (submitted: July 22, 2020)
230
Original Estimated Enrollment
 (submitted: November 13, 2018)
273
Estimated Study Completion Date September 15, 2021
Estimated Primary Completion Date March 17, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: Male
Ages 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Algeria,   Australia,   Austria,   Bulgaria,   Canada,   Croatia,   Finland,   France,   Germany,   Greece,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Poland,   Portugal,   Russian Federation,   Serbia,   Slovakia,   South Africa,   Spain,   Sweden,   Turkey,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03741881
Other Study ID Numbers NN7415-4322
U1111-1182-3359 ( Other Identifier: World Health Organization (WHO) )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Device Product: No
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
Responsible Party Novo Nordisk A/S
Study Sponsor Novo Nordisk A/S
Collaborators Not Provided
Investigators
Study Director: Clinical Reporting Anchor and Disclosure (1452) Novo Nordisk A/S
PRS Account Novo Nordisk A/S
Verification Date September 2020