UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001686 |
|---|---|
| Receipt number | R000002033 |
| Scientific Title | The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3). |
| Date of disclosure of the study information | 2009/02/06 |
| Last modified on | 2013/11/07 17:10:48 |
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Basic information
Public title
The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3).
Acronym
The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to CIN3.
Scientific Title
The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to Cervical Intraepithelial Neoplasia 3 (CIN3).
Scientific Title:Acronym
The explorative clinical trial of a HPV therapeutic vaccine using lactobacillus to CIN3.
Region
| Japan |
Condition
Condition
Cervical Intraepithelial Neoplasia 3 (CIN3)
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It aims at the first drug therapy to CIN3 by inducing the mucosal cellular immunity to HPV oncoprotein E7 with the oral vaccine using lactobacillus. In this research, it aims to confirm safety and effectiveness of this therapeutic HPV vaccine.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical safety and efficacy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine | Vaccine |
Interventions/Control_1
The therapeutic HPV vaccine will be taken in 20 days (1st to 5th, 8th to 12th, 22nd to 26th and 50th to 54th day) within all administering period (8 weeks). The dosage is assumed to be 1 to 6 capsule/time/a day.
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1) HPV16 infected women
2) whom can observe all lesioned part by colposcopic inspection
3) whom hope for conization of the cervix by patients judged that conization of the cervix is necessary
4) whom of 20 ~ 50 years old when agreement is acquired.
5) outpatient
6) All patients were required to provide written informed consent.
Key exclusion criteria
1) Person who has obviously received prohibition of using together medicine (treatment) that causes person and immune suppression that has disease that abnormality is found in immune function
2) patients of class5 in cervical cytology.
3) whom hope for laser ablation
4) patients with serious acute illness
5) patients that there are previous histories of hypersensitivity in lactobacillus content food (yogurt etc.) and preparation of lactobacillus
6) patients who has allergy for milk
7) pregnant or expected to be pregnant
8) breast feeding mother
9) whom administered other trial drugs within three months before initiation of this trial study
10) whom administered this medicine
11) whom the investigator think inappropriate as a candidate.
Target sample size
17
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kei Kawana |
Organization
The University of Tokyo Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The University of Tokyo Hospital
Division name
Department of Obstetrics & Gynecology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Sponsor or person
Institute
The University of Tokyo Hospital
Department of Obstetrics & Gynecology
Institute
Department
Personal name
Funding Source
Organization
GENOLAC BL Corp.
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
Address
Tel
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
| 2009 | Year | 02 | Month | 06 | 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
Completed
Date of protocol fixation
| 2008 | Year | 12 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 02 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 02 | Month | 04 | Day |
Last modified on
| 2013 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002033
