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NCT02568202 Clinical Trial

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

Congenital Bleeding Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02568202
Other study ID # HAEM-4268
Secondary ID U1111-1171-8168
Status Completed
Phase N/A
First received September 18, 2015
Last updated January 11, 2016
Start date September 2015
Est. completion date November 2015

Study information
Verified date January 2016
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 449
Est. completion date November 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Other:
• No treatment given
This is an online web-based cross-sectional survey in which participants will complete one of two questionnaires. There will be no treatment.

Locations
Country Name City State
United States Novo Nordisk Clinical Trial Call Center Plainsboro New Jersey

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary An online survey of Prevalence and characteristics of adults with hemophilia B At day 0 No
Primary An online survey of Prevalence and characteristics of children with hemophilia B (and their parents) At day 0 No
Primary An online survey of Prevalence of psychosocial and other comorbidities in patients with hemophilia B At day 0 No
Secondary Percentage of participants reporting difficulty with access to treatment (e.g. factor) At day 0 No
Secondary An online survey of Percentage of participants reporting difficulty with access to treatment centers At day 0 No
Secondary Percentage of participants reporting hemophilia interference with employment/education At day 0 No
Secondary Percentage of participants reporting hemophilia interference with physical activities At day 0 No
Secondary Percentage of participants reporting hemophilia interference with relationships At day 0 No
Secondary Health related quality of life: EuroQol At day 0 No
Secondary Health related quality of life:EQ-5D-5L At day 0 No
Secondary Health related quality of life: VAS (Visual Analog Scale) At day 0 No
Secondary Health related quality of life: BPI (Brief Pain Inventory) short form - Pain severity and interference At day 0 No
Secondary Health related quality of life: HAL (Hemophilia Activities List) At day 0 No
Secondary Health related quality of life: HemoCAB (Caregiver Hemophilia Burden Scale At day 0 No
Secondary Drivers of psychosocial impact (e.g. hemophilia severity, age, weight, prior treatment history, education) At day 0 No
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