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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Enrolling by invitation |
Unique ID issued by UMIN | UMIN000037488 |
Receipt No. | R000042738 |
Scientific Title | Special Drug Use Results Survey for the use of Symtuza in pregnant women |
Date of disclosure of the study information | 2019/07/26 |
Last modified on | 2020/03/06 |
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 |
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Condition | ||
Condition | HIV/AIDS | |
Classification by specialty |
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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 |
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Age-upper limit |
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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 |
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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 | ||||||
tkato1@its.jnj.com |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 |
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 |
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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 | Enrolling by invitation | ||||||
Date of protocol fixation |
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Date of IRB |
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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 | NA |
Management information | |||||||
Registered date |
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Last modified on |
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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 |