UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028248
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Evaluation of reaction and adverse events in Trichuris suis ova therapy
Acronym A Randomised double-blind placebo-controlled trial of Trichuris suis ova therapy in Japanese healthy adults
Scientific Title Evaluation of reaction and adverse events in Trichuris suis ova therapy
Scientific Title:Acronym A Randomised double-blind placebo-controlled trial of Trichuris suis ova therapy in Japanese healthy adults
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Saftey evaluation
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes Frequency of adverse events during 56 days after administration of single dose of Trichuris suis ova.
Key secondary outcomes Frequency of infection by T. suis on day 56 after administration of single dose of T. suis ova.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 TSO administration
Interventions/Control_2 TSO placebo administration
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
20 years-old <
Age-upper limit

Not applicable
Gender Male
Key inclusion criteria Healthy adult male(A person with no current and ongoing medication, without history of disease with recurrence or relapse.)
Key exclusion criteria A person who previously administered TSO and had severe adverse events. One who was judged inappropriate by the attending physician.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Hirotaka
Middle name
Last name Kanuka
Organization The Jikei University School of Medicine
Division name Department of Tropical Medicine
Zip code 105-8461
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Email kanuka@jikei.ac.jp

Public contact
Name of contact person
1st name Tokio
Middle name
Last name Hoshina
Organization The Jikei University School of Medicine
Division name Department of Infectious Disease and Control
Zip code 105-8461
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
TEL 03-3433-1111
Homepage URL
Email tohoshina@jikei.ac.jp

Sponsor
Institute The Jikei University School of Medicine
Department of Tropical Medicine
Institute
Department

Funding Source
Organization The Jikei University School of Medicine
Department of Tropical Medicine
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Jikei University School of Medicine
Address 3-25-8 Nishi-shinbashi, Minato-ku, Tokyo, Japan
Tel 3-3433-1111
Email rinri@jikei.ac.jp

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
2017 Year 09 Month 01 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 16 Day
Date of IRB
2017 Year 05 Month 16 Day
Anticipated trial start date
2017 Year 09 Month 01 Day
Last follow-up date
2019 Year 03 Month 12 Day
Date of closure to data entry
2019 Year 03 Month 12 Day
Date trial data considered complete
2019 Year 03 Month 19 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 07 Month 14 Day
Last modified on
2019 Year 09 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032283

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.