UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051639 |
|---|---|
| Receipt number | R000058923 |
| Scientific Title | Treatment Preference in Patients with Paroxysmal Nocturnal Hemoglobinuria |
| Date of disclosure of the study information | 2023/07/19 |
| Last modified on | 2024/01/22 21:30:44 |
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Basic information
Public title
Treatment Preference in Patients with Paroxysmal Nocturnal Hemoglobinuria
Acronym
Treatment Preference in Patients with Paroxysmal Nocturnal Hemoglobinuria
Scientific Title
Treatment Preference in Patients with Paroxysmal Nocturnal Hemoglobinuria
Scientific Title:Acronym
Treatment Preference in Patients with Paroxysmal Nocturnal Hemoglobinuria
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 preferences of PNH patients for treatment and factors influencing the preferences
Basic objectives2
Others
Basic objectives -Others
Patients' treatment preference
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
<Qualitative interview survey>
Relationship between preferences and background factors of treatment choice in patients with PNH.
<Quantitative questionnaire survey>
Relative preference for each attribute of PNH treatment (Candidate factors of treatment selection in the quantitative questionnaire survey).
Relative preference for each level of each attribute of PNH treatment.
Key secondary outcomes
<Qualitative interview survey>
PNH patients' subjective experience of symptoms and treatment burden and the importance of their impact on daily life.
<Quantitative questionnaire survey>
Relative preference for each attribute of PNH treatment by patient background.
Relative preference for each level of each attribute of PNH treatment by patient background.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Inclusion criteria for qualitative interview survey>
Subjects who meet all the following criteria will be included in this study.
(1) Diagnosed with PNH.
(2) Under or have had previous experience of PNH treatment.
(3) More than 16 years old at the time of consent (for those between 16 and 18 years of age, those who can understand the explanation document without the need for an assent document).
(4) Have ability to carry out the study.
(5) Provided consent to participate the study by the patient (In case the patient is less than 18 years old, consent from both the patient and her/his legal representative is required).
(6) Have ability to complete the procedures of the protocol.
(7) Live in Japan at the time of consent.
(8) Have the equipment and suited environment for communication to conduct the interviews.
<Inclusion criteria for the quantitative questionnaire survey>
Subjects who meet all the following criteria will be included in the study.
(1) Diagnosed with PNH.
(2) Under or have had previous experience of PNH treatment.
(3) More than 16 years old at the time of consent (for those between 16 and 18 years of age, those who can understand the explanation document without the need for a special assent document).
(4) Have ability to carry out the study.
(5) Provided consent to participate the study by the patient (In case the patient is less than 18 years old, consent from both the patient and her/his legal representative is required).
(6) Have ability to complete the procedures of the protocol.
(7) Live in Japan at the time of consent.
(8) Have the equipment and suited environment for communication to complete the web entry and survey.
*Those who participated in the qualitative survey can also participate in the quantitative survey if they meet the above inclusion criteria.
Key exclusion criteria
Subjects who meet following criteria will be excluded from the study.
(1) Have difficulty in obtaining consent or conducting this study due to lack of Japanese language skills.
(2) Unable to participate in the survey in person.
Target sample size
140
Research contact person
Name of lead principal investigator
| 1st name | Jun-Ichi |
| Middle name | |
| Last name | Nishimura |
Organization
Japan PNH Study Group
Division name
-
Zip code
103-0025
Address
Kyodo Kaihatsu Building 3F, 2-17-4 Nihonbashi Kayabacho, Chuo-ku, Tokyo
TEL
03-6810-9713
junnishi@bldon.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Chugai Pharmaceutical |
| Middle name | |
| Last name | Co., Ltd. |
Organization
Medical Affairs Div.
Division name
Specialty Medical Science Dept.
Zip code
103-8324
Address
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo
TEL
03-3281-6611
Homepage URL
cma-clinicaltrial@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Japan PNH Study Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
5-20-9-401, Mita, Minato-ku, Tokyo 108-0073
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
| 2023 | Year | 07 | Month | 19 | 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
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
Suspended
Date of protocol fixation
| 2023 | Year | 06 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 24 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Qualitative interview survey>
30 subjects
<Quantitative questionnaire survey>
Pilot survey 10 subjects, Main survey 100 subjects
Management information
Registered date
| 2023 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058923
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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