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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020469
Receipt No. R000023651
Scientific Title Treatment of neonatal hemochromatosis with high-dose intravenous immunoglobulin during pregnancy
Date of disclosure of the study information 2016/01/13
Last modified on 2018/07/10

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Basic information
Public title Treatment of neonatal hemochromatosis with high-dose intravenous immunoglobulin during pregnancy
Acronym Treatment of neonatal hemochromatosis with high-dose intravenous immunoglobulin during pregnancy
Scientific Title Treatment of neonatal hemochromatosis with high-dose intravenous immunoglobulin during pregnancy
Scientific Title:Acronym Treatment of neonatal hemochromatosis with high-dose intravenous immunoglobulin during pregnancy
Region
Japan

Condition
Condition neonatal haemochromatosis
Classification by specialty
Obsterics and gynecology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effectiveness in preventing or changing the severity of recurrent neonatal haemochromatosis of administering during pregnancy high-dose intravenous immunoglobulin.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Assessment of the effectiveness in preventing the severity of recurrent neonatal haemochromatosis:
monitoring of the mother's health and the progress of pregnanacy
monitering of the infant's health, liver function and development
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 The treatment consisted of intravenous immunoglobulin administered weekly at a dose of 1 g per kg bodyweight from the 18th week until the end of gestation.
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 Female
Key inclusion criteria Women who were pregnant were identified as candidates for treatment if they
had a previous infant or fetus affected with neonatal hemochromatosis and, therefore, were considered to be at high risk to have another.
Key exclusion criteria Women who had allergy for immunoglobulin.
Target sample size 2

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yusuke Mitani
Organization School of Medicine, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University
Division name Department of Pediatrics
Zip code
Address 13-1 Takaramachi, Kanazawa, 920-8641, Japan
TEL 076-265-2313
Email ped.yusuke@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Mitani
Organization School of Medicine, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University
Division name Department of Pediatrics
Zip code
Address 13-1 Takaramachi, Kanazawa, 920-8641, Japan
TEL 076-265-2313
Homepage URL
Email ped.yusuke@gmail.com

Sponsor
Institute Department of Pediatrics, School of Medicine, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department

Funding Source
Organization Department of Pediatrics, School of Medicine, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University
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
2016 Year 01 Month 13 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 No longer recruiting
Date of protocol fixation
2010 Year 09 Month 09 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 22 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
2016 Year 01 Month 07 Day
Last modified on
2018 Year 07 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023651

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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