UMIN-CTR Clinical Trial

Basic information
Public title	Special Drug Use Results Survey for the use of Symtuza in pregnant women
Acronym	Special Drug Use Results Survey for the use of Symtuza in pregnant women
Scientific Title	Special Drug Use Results Survey for the use of Symtuza in pregnant women
Scientific Title:Acronym	Special Drug Use Results Survey for the use of Symtuza in pregnant women
Region	Japan

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

Objectives
Narrative objectives1	To collect and review information on factors affecting safety, such as setting of occurrence of adverse events under actual use conditions, and effects on infant in patients with HIV infection receiving Symtuza during pregnancy.
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 receive Symtuza during pregnancy and whose outcome of pregnancy can be confirmed.
Key exclusion criteria	NA
Target sample size	3

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, Nishikanda 3-chome, Chiyoda-ku, Tokyo
TEL	03-4411-5017
Email	tkato1@its.jnj.com

Public contact
Name of contact person	1st name Masayuki Middle name Last name Takagishi
Organization	Janssen Pharmaceutical K.K.
Division name	Safety Risk Management Dept.
Zip code	101-0065
Address	5-2, Nishikanda 3-chome, Chiyoda-ku, Tokyo
TEL	03-4411-5464
Homepage URL
Email	mtakagis@its.jnj.com

Sponsor
Institute	Janssen Pharmaceutical K.K.
Institute
Department

Funding Source
Organization	Janssen Pharmaceutical K.K.
Organization
Division
Category of Funding Organization	Self funding
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, Nishikanda 3-chome, Chiyoda-ku, Tokyo
Tel	03-4411-5104
Email	mtakagis@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	2019 Year 07 Month 26 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	2019 Year 06 Month 20 Day
Date of IRB	2019 Year 06 Month 20 Day
Anticipated trial start date	2019 Year 07 Month 26 Day
Last follow-up date	2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	NA

Management information
Registered date	2019 Year 07 Month 25 Day
Last modified on	2020 Year 03 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042738

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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