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

Completed

• Conditions: Haemostasis; Haemophilia B; Congenital Bleeding Disorder
• Interventions: Other: No treatment given

• Registration Number: NCT02568202
• Lead Sponsor: Novo Nordisk A/S

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-18
• Study First Submitted QC: 2015-10-01
• Study First Posted: 2015-10-05
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-11
• Last Update Posted: 2016-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 449

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survey	No treatment given	-

Primary Outcome Measures

Name	Time	Method
An online survey of Prevalence and characteristics of adults with hemophilia B	At day 0
An online survey of Prevalence and characteristics of children with hemophilia B (and their parents)	At day 0
An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B	At day 0

Secondary Outcome Measures

Name	Time	Method
Percentage of participants reporting difficulty with access to treatment (e.g. factor)	At day 0
An online survey of Percentage of participants reporting difficulty with access to treatment centers	At day 0
Percentage of participants reporting hemophilia interference with employment/education	At day 0
Percentage of participants reporting hemophilia interference with physical activities	At day 0
Percentage of participants reporting hemophilia interference with relationships	At day 0
Health related quality of life: EuroQol	At day 0
Health related quality of life:EQ-5D-5L	At day 0
Health related quality of life: VAS (Visual Analog Scale)	At day 0
Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference	At day 0
Health related quality of life: HAL (Hemophilia Activities List)	At day 0
Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale	At day 0
Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education)	At day 0

Trial Locations

Locations (1)

Novo Nordisk Clinical Trial Call Center; 🇺🇸 Plainsboro, New Jersey, United States