UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054172 |
|---|---|
| Receipt number | R000059697 |
| Scientific Title | "Living well with PNH" - an ethnografic study exploring the lived experience of PNH from a patient and HCP perspective in Japan |
| Date of disclosure of the study information | 2024/04/17 |
| Last modified on | 2024/04/17 08:18:03 |
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Basic information
Public title
"Living well with PNH" - an ethnografic study exploring the lived experience of PNH from a patient and HCP perspective in Japan
Acronym
"Living well with PNH" - an ethnografic study exploring the lived experience of PNH from a patient and HCP perspective in Japan
Scientific Title
"Living well with PNH" - an ethnografic study exploring the lived experience of PNH from a patient and HCP perspective in Japan
Scientific Title:Acronym
"Living well with PNH" - an ethnografic study exploring the lived experience of PNH from a patient and HCP perspective in Japan
Region
| Japan |
Condition
Condition
Paroxysmal Nocturnal Hemoglobinuria
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To understand what it means to live well with PNH for patients and their carers and to identifying aspirations, barriers and unmet needs for patients and carers living with PNH
Basic objectives2
Others
Basic objectives -Others
Uncovering the dynamics among patients, carers, physicians and nurses when it comes to treatment decisions
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
N/A
Key secondary outcomes
N/A
Base
Study type
Others,meta-analysis etc
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Respondents must fulfill the following criteria in order to be included in the study:
Patient:
1.18 years old or older
2.Confirmed diagnosis of PNH
3.C5 treatment experience (Currently on C5 treatment)
4.Signed informed consent fot the study
HCP:
1. works at a medical institution where patients with PNH are seen
2. treats patients with PNH
3. Signed informed consent fot the study
Key exclusion criteria
The presence of the following will exclude a subject from inclusion in the study:
Patient:
1.Enrollment or participation in market research or another ethnographic study about PNH within the past 3 months
2.Enrollment or participation in a clinical trial currently
HCP:
N/A
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Anne Mette |
| Middle name | Worsoe |
| Last name | Lottrup |
Organization
ReD Associates
Division name
N/A
Zip code
1306
Address
Kronprinsessegade 20, 1306 Copenhagen, Denmark
TEL
+4526116528
alo@redassociates.com
Public contact
Name of contact person
| 1st name | Anne Mette |
| Middle name | Worsoe |
| Last name | Lottrup |
Organization
ReD Associates
Division name
N/A
Zip code
1306
Address
Kronprinsessegade 20, 1306 Copenhagen, Denmark
TEL
+81-3-4400-6872
Homepage URL
SobiJapanContact@sobi.com
Sponsor or person
Institute
ReD Associates
Institute
Department
Personal name
Funding Source
Organization
Swedish Orphan Biovitrum Japan
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
MINS REC
Address
1-15-14, Dogenzaka, Shibuya-ku, Tokyo, 150-0043, Japan
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
8
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Hands-on (or virtual) investigation of patients' daily lives using a variety of techniques, including semi-structured interviews, simple exercises and observations with patients and HCPs
Management information
Registered date
| 2024 | Year | 04 | Month | 17 | Day |
Last modified on
| 2024 | Year | 04 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059697
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
