Survey Evaluating the Psychosocial Effects of Living With Haemophilia (HERO)

Novo Nordisk

Status: Completed

Conditions: Haemophilia B With Inhibitors; Haemophilia B; Haemophilia A With Inhibitors; Relatives to/Carers of Patients; Haemophilia A; Congenital Bleeding Disorder

Treatments: Other: No treatment given

Study type: Observational

Funder types: Industry

Identifiers

NCT01322620

F7HAEM-3911

U1111-1119-7128 (Other Identifier)

Details and patient eligibility

About

This study is conducted in Africa, Asia, Europe, North America and South America.

The purpose of the survey is to identify the key psychosocial issues affecting patients with haemophilia.

Enrollment: 1,236 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males with haemophilia A or B (with or without inhibitors)
• Parents/carers of children aged below 18 years with haemophilia A or B (with or without inhibitors)
• Patients currently receiving treatment for haemophilia with one of the following: replacement factor VIII or replacement factor IX or a bypassing agent (recombinant factor VIIa or aPCC (Activated prothrombin complex concentrate))
• Patients with haemophilia, not currently receiving treatment with replacement factor VIII or IX or a bypassing agent (as appropriate), but who have had at least one spontaneous bleed into one or more joints within the last 12 months
• Subjects must have access to the internet, either at home or at a location convenient to them, be able to complete a paper questionnaire, or be available to attend a face-to-face interview (Algerian subjects only), to participate in the survey

Exclusion criteria

• Inability to understand and comply with written and verbal instructions unless assisted at the haemophilia treatment centre (HTC) or by a relative

Trial design

1,236 participants in 1 patient group

A

Treatment:

Other: No treatment given