UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030626
Receipt No. R000034969
Scientific Title Investigation on the effectiveness of histidine copper treatment of Menkes disease patients
Date of disclosure of the study information 2017/12/28
Last modified on 2018/03/15

* 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 Investigation on the effectiveness of histidine copper treatment of Menkes disease patients
Acronym Investigation on the effectiveness of histidine copper treatment of Menkes disease patients
Scientific Title Investigation on the effectiveness of histidine copper treatment of Menkes disease patients
Scientific Title:Acronym Investigation on the effectiveness of histidine copper treatment of Menkes disease patients
Region
Japan

Condition
Condition Menkes disease
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of histidine copper treatment in Menkes' disease patients is said to be different depending on the timing of treatment start and gene mutation. The purpose of this study is to clarify the effect of histidine copper on each symptom of Menkes' disease patients participating in the study. In addition, we aim to contribute to the treatment of subjects and other Menkes' disease patients by clarifying that copper deficiency is prevented / improved by histidine copper administration.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes development
Key secondary outcomes The presence or absence of spasm

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 Weekly,subcutaneous injection of histidine copper (750microgram once) is performed three times per week.It is continued every week until the end of the research during the research period.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Those who have written explanation and consent from patients who want family history of histidine copper treatment in Menkes disease patients
Key exclusion criteria None
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tokiko Fukuda
Organization Hamamatsu University School of Medicine
Division name Department of Pediatrics
Zip code
Address 1-20-1 Hamdayama,Higashi-ku,Hamamatsu-city,Shizuoka
TEL 053-435-2638
Email toki-fkd@hama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tokiko Fukuda
Organization Hamamatsu University School of Medicine
Division name Department of Pediatrics
Zip code
Address 1-20-1 Hamdayama,Higashi-ku,Hamamatsu-city,Shizuoka
TEL 053-435-2638
Homepage URL
Email toki-fkd@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

Funding Source
Organization Self funding
Organization
Division
Category of Funding Organization Self funding
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
2017 Year 12 Month 28 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
2014 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 11 Month 28 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2018 Year 03 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034969

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.