UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034028
Receipt number R000038793
Scientific Title Special Drug Use Results Surveillance for the use of Odefsey in pregnant women
Date of disclosure of the study information 2018/09/20
Last modified on 2020/03/06 17:50:47

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Basic information

Public title

Special Drug Use Results Surveillance for the use of Odefsey in pregnant women

Acronym

Special Drug Use Results Surveillance for the use of Odefsey in pregnant women

Scientific Title

Special Drug Use Results Surveillance for the use of Odefsey in pregnant women

Scientific Title:Acronym

Special Drug Use Results Surveillance for the use of Odefsey in pregnant women

Region

Japan


Condition

Condition

HIV/AIDS

Classification by specialty

Infectious disease Hepato-biliary-pancreatic surgery

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 Odefsey 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 Odefsey 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, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo

TEL

03-4411-5017

Email

tkato1@its.jnj.com


Public contact

Name of contact person

1st name Masayuk
Middle name
Last name Takagishii

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

03-4411-5464

Homepage URL


Email

mtakagis@its.jnj.com


Sponsor or person

Institute

Janssen Pharmaceutical K.K.

Institute

Department

Personal name



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

03-4411-5464

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

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

2020 Year 03 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038793


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name