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


Email



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


Email



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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name