UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000020469
Receipt number 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 14:42:09

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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

Obstetrics 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 or person

Institute

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

Institute

Department

Personal name



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

Value
https://center6.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