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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034026
Receipt No. R000038792
Scientific Title Odefsey Drug Use Results Survey
Date of disclosure of the study information 2018/09/20
Last modified on 2019/09/05

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Basic information
Public title Odefsey Drug Use Results Survey
Acronym Odefsey Drug Use Results Survey
Scientific Title Odefsey Drug Use Results Survey
Scientific Title:Acronym Odefsey Drug Use Results Survey
Region
Japan

Condition
Condition HIV/AIDS
Classification by specialty
Infectious disease
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To confirm the safety and efficacy of Odefsey under actual use conditions in patients with HIV infection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Safety (ADR)
Effectiveness(Changes in HIV-RNA level, Changes in CD4 lymphocyte count)
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients with HIV infection who received Odefsey
Key exclusion criteria NA
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Toshiya
Middle name
Last name Kato
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept.
Zip code 101-0065
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5478
Email tkato1@its.jnj.com

Public contact
Name of contact person
1st name Genta
Middle name
Last name Kawaguchi
Organization Janssen Pharmaceutical K.K.
Division name Safety Risk Management Dept.
Zip code 101-0065
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL 03-4411-5104
Homepage URL
Email gkawagu@its.jnj.com

Sponsor
Institute Janssen Pharmaceutical K.K.
Institute
Department

Funding Source
Organization Janssen Pharmaceutical 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 Janssen Pharmaceutical K.K.
Address 5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
Tel 03-4411-5104
Email gkawagu@its.jnj.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
2018 Year 09 Month 20 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 27 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective study

Management information
Registered date
2018 Year 09 Month 04 Day
Last modified on
2019 Year 09 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038792

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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