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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01322620
Other study ID # F7HAEM-3911
Secondary ID U1111-1119-7128
Status Completed
Phase N/A
First received March 23, 2011
Last updated February 20, 2017
Start date June 3, 2011
Est. completion date February 29, 2012

Study information

Verified date February 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 1236
Est. completion date February 29, 2012
Est. primary completion date February 29, 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Other:
No treatment given
No treatment given. Participants are to complete a questionnarie in the study.

Locations

Country Name City State
Canada Novo Nordisk Investigational Site Mississauga
Spain Novo Nordisk Investigational Site Madrid
United Kingdom Novo Nordisk Investigational Site Crawley

Sponsors (1)

Lead Sponsor Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

Canada,  Spain,  United Kingdom, 

References & Publications (2)

Forsyth AL, Gregory M, Nugent D, Garrido C, Pilgaard T, Cooper DL, Iorio A. Haemophilia Experiences, Results and Opportunities (HERO) Study: survey methodology and population demographics. Haemophilia. 2014 Jan;20(1):44-51. doi: 10.1111/hae.12239. — View Citation

Witkop M, Guelcher C, Forsyth A, Hawk S, Curtis R, Kelley L, Frick N, Rice M, Rosu G, Cooper DL. Treatment outcomes, quality of life, and impact of hemophilia on young adults (aged 18-30 years) with hemophilia. Am J Hematol. 2015 Dec;90 Suppl 2:S3-10. doi — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To quantify the extent of key psychosocial factors affecting patients with haemophilia in their daily lives After 6 weeks (recruitment and data collection)
Secondary To quantify how psychosocial factors are associated with treatment outcomes, compliance, health and general well-being After 6 weeks (recruitment and data collection)
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