Unique ID issued by UMIN | UMIN000028248 |
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Receipt number | R000032283 |
Scientific Title | Evaluation of reaction and adverse events in Trichuris suis ova therapy |
Date of disclosure of the study information | 2017/09/01 |
Last modified on | 2019/09/11 17:42:03 |
Evaluation of reaction and adverse events in Trichuris suis ova therapy
A Randomised double-blind placebo-controlled trial of Trichuris suis ova therapy in Japanese healthy adults
Evaluation of reaction and adverse events in Trichuris suis ova therapy
A Randomised double-blind placebo-controlled trial of Trichuris suis ova therapy in Japanese healthy adults
Japan |
Healthy adult
Adult |
Others
NO
Saftey evaluation
Safety
Confirmatory
Pragmatic
Phase I
Frequency of adverse events during 56 days after administration of single dose of Trichuris suis ova.
Frequency of infection by T. suis on day 56 after administration of single dose of T. suis ova.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
2
Prevention
Other |
TSO administration
TSO placebo administration
20 | years-old | < |
Not applicable |
Male
Healthy adult male(A person with no current and ongoing medication, without history of disease with recurrence or relapse.)
A person who previously administered TSO and had severe adverse events. One who was judged inappropriate by the attending physician.
12
1st name | Hirotaka |
Middle name | |
Last name | Kanuka |
The Jikei University School of Medicine
Department of Tropical Medicine
105-8461
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
03-3433-1111
kanuka@jikei.ac.jp
1st name | Tokio |
Middle name | |
Last name | Hoshina |
The Jikei University School of Medicine
Department of Infectious Disease and Control
105-8461
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
03-3433-1111
tohoshina@jikei.ac.jp
The Jikei University School of Medicine
Department of Tropical Medicine
The Jikei University School of Medicine
Department of Tropical Medicine
Other
The Jikei University School of Medicine
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
3-3433-1111
rinri@jikei.ac.jp
NO
2017 | Year | 09 | Month | 01 | Day |
Unpublished
Preinitiation
2017 | Year | 05 | Month | 16 | Day |
2017 | Year | 05 | Month | 16 | Day |
2017 | Year | 09 | Month | 01 | Day |
2019 | Year | 03 | Month | 12 | Day |
2019 | Year | 03 | Month | 12 | Day |
2019 | Year | 03 | Month | 19 | Day |
2019 | Year | 03 | Month | 31 | Day |
2017 | Year | 07 | Month | 14 | Day |
2019 | Year | 09 | Month | 11 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032283
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