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Completed

NCT Number: NCT02568202

Bridging Hemophilia B Experiences, Results and Opportunities Into Solutions (B-HERO-S)

This study is conducted in the United States of America (USA). Tha aim of this study is bridging Hemophilia B Experiences, Results and Opportunities into Solutions (B-HERO-S).

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Key information

Conditions

Haemostasis Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital Bleeding Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Genetic Diseases, X-Linked Haemophilia B Hematologic Diseases Hemic and Lymphatic Diseases Hemophilia B Hemorrhagic Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Novo Nordisk Clinical Trial Call Center

Plainsboro, New Jersey, 08536, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults aged below or equal to 18 years with hemophilia B (any severity, with or without inhibitors)
  • Caregivers of children currently aged below 18 years with hemophilia B (any severity, with or without inhibitors)
  • Subjects must have access to the internet, either at home or at a location convenient to them
  • Provision of informed consent before the start of any survey-related activities

Exclusion criteria

  • Inability to understand and comply with written instructions in English
  • Previous completion of the B-HERO-S study with receipt of compensation
  • Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation

Treatment and study plan

No treatment given

Other

This is an online web-based cross-sectional survey in which participants will complete one of two questionnaires.

There will be no treatment.

Primary outcomes

  1. An online survey of Prevalence and characteristics of adults with hemophilia B

    Time frame: At day 0

  2. An online survey of Prevalence and characteristics of children with hemophilia B (and their parents)

    Time frame: At day 0

  3. An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B

    Time frame: At day 0

Secondary outcomes

  1. Percentage of participants reporting difficulty with access to treatment (e.g. factor)

    Time frame: At day 0

  2. An online survey of Percentage of participants reporting difficulty with access to treatment centers

    Time frame: At day 0

  3. Percentage of participants reporting hemophilia interference with employment/education

    Time frame: At day 0

  4. Percentage of participants reporting hemophilia interference with physical activities

    Time frame: At day 0

  5. Percentage of participants reporting hemophilia interference with relationships

    Time frame: At day 0

  6. Health related quality of life: EuroQol

    Time frame: At day 0

  7. Health related quality of life:EQ-5D-5L

    Time frame: At day 0

  8. Health related quality of life: VAS (Visual Analog Scale)

    Time frame: At day 0

  9. Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference

    Time frame: At day 0

  10. Health related quality of life: HAL (Hemophilia Activities List)

    Time frame: At day 0

  11. Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale

    Time frame: At day 0

  12. Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education)

    Time frame: At day 0

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 5, 2015
Registry last updated
Jan 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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