UMIN ID: UMIN000054086
Registered date:09/04/2024
A survey study of HAE patients: mental QoL and treatment preferences
Basic Information
| Recruitment status | Pending |
|---|---|
| Health condition(s) or Problem(s) studied | Hereditary angioedema: HAE |
| Date of first enrollment | 2024/04/10 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | The impact and degree that HAE affects anxiety and depression as well as angioedema-related quality of life (QoL) in Japanese HAE patients: HADS, AE-QoL |
|---|---|
| Secondary Outcome | 1)The treatment satisfaction in Japanese HAE patients:TSQM-9 2)The impact of HAE on the work productivity and generic health status in Japanese HAE patients:EQ-5D-5L,WPAI-GH 3)Patients' most important factor for deciding medication preference for HAE in Japanese patients 4)The impacts of the demographics, clinical and disease characteristics on HADS in Japanese HAE patients |
Key inclusion & exclusion criteria
| Age minimum | 12years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Participants who meet any of the following exclusion criteria will be excluded from participation in this study: 1)Participants who are not members of either the HAEJ or CREATE patient groups 2)Participants who have already responded to this study via the other patient group |
Related Information
| Primary Sponsor | CSL Behring K.K |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | CSL Behring K.K. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Michael LOPRESTI |
| Address | 13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan Japan 101-0062 |
| Telephone | 050-3640-1444 |
| m.lopresti@intage.com | |
| Affiliation | INTAGE Healthcare Inc Value & Access Department |
| scientific contact | |
| Name | Naoki Terasaka |
| Address | 1-2-3 Kita-aoyama, Minato-ku, Tokyo 107-0061, Japan Japan |
| Telephone | 070-8702-1080 |
| Naoki.Terasaka@cslbehring.com | |
| Affiliation | CSL Behring K.K. Medical Affairs |