UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Treatment of neonatal hemochromatosis with high-dose intravenous immunoglobulin during pregnancy
Title of the study (Brief title)	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	Yusuke Mitani
Organization	School of Medicine, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University
Division name	Department of Pediatrics
Address	13-1 Takaramachi, Kanazawa, 920-8641, Japan
TEL	076-265-2313
Email	ped.yusuke@gmail.com

Public contact
Name of contact person	Yusuke Mitani
Organization	School of Medicine, Institute of Medical Pharmaceutical and Health Sciences, Kanazawa University
Division name	Department of Pediatrics
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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2010 Year 09 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000023651