UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053713 |
|---|---|
| Receipt number | R000061258 |
| Scientific Title | Patient and Physician Preferences for Treatment for Hepatitis C Virus Infection in Japan: A Discrete Choice Experiment |
| Date of disclosure of the study information | 2024/03/04 |
| Last modified on | 2024/02/22 15:07:03 |
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Basic information
Public title
Patient and Physician Preferences for Treatment for Hepatitis C Virus Infection in Japan: A Discrete Choice Experiment
Acronym
Preference Study on Treatment of HCV using DCE
Scientific Title
Patient and Physician Preferences for Treatment for Hepatitis C Virus Infection in Japan: A Discrete Choice Experiment
Scientific Title:Acronym
Preference Study on Treatment of HCV using DCE
Region
| Japan |
Condition
Condition
Hepatitis C Virus Infection
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elicit specific patient and physician preferences for treatment of HCV, which are important to maintain good adherence and work toward HCV elimination in Japan.
Basic objectives2
Others
Basic objectives -Others
To describe the proportion of each attribute of HCV treatment on the patient and physician perspectives.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient and physician preferences regarding HCV treatment.
Key secondary outcomes
Shared decision-making process for HCV treatment on patient and physician perspectives.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Participants must meet all the following inclusion/exclusion criteria.
[Patients]
1)Age 18 and above.
2)Individuals who self-report past or present HCV infection including 1) patients who have received drug therapy for HCV within the past 5 years and 2) patients who have never received any drug therapy for HCV but still presently have HCV.
3)Able to provide informed consent to participate in the study and willing to participate in the study.
[Physicians]
1)At least 3 years of clinical experience, including the period of clinical training.
2)Specializing in gastroenterology or gastroenterological surgery or general internal medicine.
3)Qualified as hepatologists by the Japan Society of Hepatology OR/AND gastroenterologists by the Japanese Society of Gastroenterology.
4)Having treated at least 1 patient with HCV and have prescribed drug therapy for HCV in the past.
5)Able to provide informed consent to participate in the study and willing to participate in the study.
Key exclusion criteria
[Patients]
1)Patients with suspected liver cirrhosis.
2)Patients with concomitant carcinoma.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Nakamoto |
Organization
Gilead Sciences K.K.
Division name
Medical affairs-Liver Diseases Area
Zip code
100-6616
Address
16F GranTokyo South Tower, 1-9-2 Marunouchi, Chiyoda-ku, Tokyo 100-6616, Japan
TEL
03-6837-0055
Daisuke.Nakamoto@gilead.com
Public contact
Name of contact person
| 1st name | Michael |
| Middle name | |
| Last name | LOPRESTI |
Organization
INTAGE Healthcare Inc.
Division name
Value & Access Department
Zip code
101-0062
Address
13F Ochanomizu SolaCity, 4-6 Kanda-Surugadai, Chiyoda-ku, Tokyo 101-0062, Japan
TEL
050-3640-1444
Homepage URL
m.lopresti@intage.com
Sponsor or person
Institute
Gilead Sciences K.K.
Institute
Department
Personal name
Funding Source
Organization
Gilead Sciences K.K.
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
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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 | 03 | Month | 04 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 02 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 11 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Method: Web-based survey to investigate treatment preferences for HCV patients and physicians.
Utilize discrete choice experiments to measure treatment preferences.
Management information
Registered date
| 2024 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061258
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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