UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006676
Receipt number R000007886
Scientific Title Evaluation of affect to serum concentration of (1-3)bata-D Glucan by IVIG administration
Date of disclosure of the study information 2011/11/14
Last modified on 2023/05/17 13:07:23

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Basic information

Public title

Evaluation of affect to serum concentration of (1-3)bata-D Glucan by IVIG administration

Acronym

Evaluation of affect to serum concentration of (1-3)bata-D Glucan by IVIG administration

Scientific Title

Evaluation of affect to serum concentration of (1-3)bata-D Glucan by IVIG administration

Scientific Title:Acronym

Evaluation of affect to serum concentration of (1-3)bata-D Glucan by IVIG administration

Region

Japan


Condition

Condition

Invasive fungal infections

Classification by specialty

Infectious disease Emergency medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

evaluation of serum consentration of 1-3 beta-D glucan affected by administration of IVIG

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

serum consentration of 1-3 beta-D glucan

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

Diagnosis

Type of intervention

Medicine

Interventions/Control_1

Administration of IVIG

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

patient with admitted Gifu university hospital Advanced Critical Care Center and administrated by IVIG

Key exclusion criteria

reject to informed consent

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Noriaki Yamada

Organization

Gifu University

Division name

University Hospital

Zip code


Address

Yanagido 1-1 Gifu

TEL


Email



Public contact

Name of contact person

1st name
Middle name
Last name

Organization

University Hospital

Division name

Advanced Critical Care Center

Zip code


Address


TEL

058-230-6448

Homepage URL


Email



Sponsor or person

Institute

Gifu University Hospital
Advanced Critical Care Center

Institute

Department

Personal name



Funding Source

Organization

Gifu University Hospital
Advanced Critical Care Center

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

2011 Year 11 Month 14 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

Terminated

Date of protocol fixation

2011 Year 11 Month 01 Day

Date of IRB

2011 Year 10 Month 07 Day

Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2012 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

2011 Year 11 Month 07 Day

Last modified on

2023 Year 05 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007886


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name