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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000047727 |
Receipt No. | R000054380 |
Scientific Title | Prospective study of patient / patient's caregiver and physician preferences for treatment of hemophilia |
Date of disclosure of the study information | 2022/05/13 |
Last modified on | 2022/05/12 |
Basic information | ||
Public title | Prospective study of patient / patient's caregiver and physician preferences for treatment of hemophilia | |
Acronym | Prospective study of preferences for treatment of hemophilia | |
Scientific Title | Prospective study of patient / patient's caregiver and physician preferences for treatment of hemophilia | |
Scientific Title:Acronym | Prospective Study of Preferences for Treatment of Hemophilia | |
Region |
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Condition | ||||
Condition | Hemophilia | |||
Classification by specialty |
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Classification by malignancy | Others | |||
Genomic information | NO |
Objectives | |
Narrative objectives1 | Examine and quantify preferences of patient /patients caregiver and physician for regular treatment of hemophilia |
Basic objectives2 | Others |
Basic objectives -Others | Examine the similarities and differences in perceptions of treatment between patient/patient's caregiver and physician |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | Pragmatic |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Examine the similarities and differences in perceptions of treatment between patient/patient's caregiver and physician (DCE) |
Key secondary outcomes | Examine the similarities and differences in perceptions of treatment between patient/patient's caregiver and physician. |
Base | |
Study type | Observational |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients
1) Age 18 years or older 2) Current without inhibitor 3) Has 6 months or more experience with self-injection of prophylactic treatment with a coagulation factor preparation 4) Willing and able to provide consent, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study Patient caregivers 1) Caregiver of hemophilia under 18 years 2) Caregiver of patient currently without inhibitor 3) Has 6 months or more experience with injection of prophylactic treatment with a coagulation factor preparation 4) Willing and able to provide consent, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study Physicians 1) Targeted specialists (general internists medicine, hematologists, pediatrics) 2) Have treated at least one patient with hemophilia with drugs within the past year 3) Willing and able to provide consent, indicating that they understand the purpose and procedures required for the study and are willing to participate in the study |
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Key exclusion criteria | Those that do not meet the inclusion criteria | |||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Novo Nordisk Pharma Ltd | ||||||
Division name | Medical Affairs Department | ||||||
Zip code | 100-0005 | ||||||
Address | 2-1-1 Marunouchi, Chiyoda-ku, Tokyo, Japan | ||||||
TEL | +81362661000 | ||||||
ayud@novonordisk.com |
Public contact | |||||||
Name of contact person |
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Organization | INTAGE Healthcare Inc. | ||||||
Division name | Health Economics & Outcomes Research Division | ||||||
Zip code | 101-0062 | ||||||
Address | 13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo | ||||||
TEL | +815036401444 | ||||||
Homepage URL | https://www.intage-healthcare.co.jp/ | ||||||
m.lopresti@intage.com |
Sponsor | |
Institute | INTAGE Healthcare, Inc. |
Institute | |
Department |
Funding Source | |
Organization | Novo Nordisk Pharma Ltd |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
Nationality of Funding Organization | Japan |
Other related organizations | |
Co-sponsor | |
Name of secondary funder(s) |
IRB Contact (For public release) | |
Organization | Medical Corporation Keiaikai Saga Memorial Hospital |
Address | 1240-1 Takagise-cho, Saga City, Saga Prefecture |
Tel | 0952-31-7771 |
sagakinen8490917@gmail.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 |
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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 | Preinitiation | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | Before start |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054380 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |