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

NCT02568202 | Completed

• 2 other identifiers: HAEM-4268U1111-1171-8168
• Study Type: observational
• Target: 449
• Locations: 1 country
• Sites: 1

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).

Conditions

Haemostasis; Congenital Bleeding Disorder; Haemophilia B

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (12)

• 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

Study Arms (1)

Survey

Other: No treatment given

Interventions

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.

Survey

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This study will investigate adult patients at least 18 years of age with mild-severe hemophilia B and caregivers of children (current age below 18 years) with hemophilia B.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Clinical Trial Call Center

Plainsboro, New Jersey, 08536, United States

Location

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, X-Linked

Study Officials

• Global Clinical Registry (GCR, 1452)

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2015
• First Posted: October 5, 2015
• Study Start: September 1, 2015
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (1)