UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004492 |
|---|---|
| Receipt number | R000005370 |
| Scientific Title | Clinical trial aimed at new therapeutic approch against HAM patients by pentosan polysulphate |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2012/05/25 09:07:18 |
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Basic information
Public title
Clinical trial aimed at new therapeutic approch against HAM patients by pentosan polysulphate
Acronym
Clinical trial against HAM patients by pentosan polysulphate
Scientific Title
Clinical trial aimed at new therapeutic approch against HAM patients by pentosan polysulphate
Scientific Title:Acronym
Clinical trial against HAM patients by pentosan polysulphate
Region
| Japan |
Condition
Condition
HTLV-I associated myelopathy (HAM)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verification of efficacy and safety of pentosan polysulphate as new remedy for HAM targeting the inhibition of HTLV-I cell to cell spread in vivo
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of neurological signs,
Improvement of neurogenic bladder,
Decrease of HTLV-I proviral load in peripheral blood,
Check of side effects
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 |
Interventions/Control_1
Subcutaneous injection once a week (1st 25mg, 2nd 50mg, 100 mg after 3rd injection) for 8 weeks followed by observation for another 4 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
HAM patients who fulfilled the diagnostic criteria of WHO
Key exclusion criteria
patients who both prothrombin time and activated partial thromboplastin time are more than normal ranges at screening test
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tatsufumi Nakamura |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Department of Molecular Microbilogy and Immunology
Zip code
Address
1-12-4 Sakamoto, Nagasaki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate School of Biomedical Sciences, Nagasaki University
Division name
Department of Molecular Microbilogy and Immunology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Molecular Microbilogy and Immunology
Institute
Department
Personal name
Funding Source
Organization
FS stage/2010, A-STEP, Japan Science and Technology Agency (JST)
Organization
Division
Category of Funding 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
| 2010 | Year | 11 | 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
Completed
Date of protocol fixation
| 2010 | Year | 10 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 11 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 01 | Day |
Last modified on
| 2012 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005370
