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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003034
Receipt No. R000003475
Scientific Title High-dose intravenous immunoglobulin therapy for refractory viral infection after allogeneic hematopoietic stem cell transplantation.
Date of disclosure of the study information 2010/01/14
Last modified on 2018/12/03

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Basic information
Public title High-dose intravenous immunoglobulin therapy for refractory viral infection after allogeneic hematopoietic stem cell transplantation.
Acronym High-dose intravenous immunoglobulin therapy for refractory viral infection after allogeneic hematopoietic stem cell transplantation.
Scientific Title High-dose intravenous immunoglobulin therapy for refractory viral infection after allogeneic hematopoietic stem cell transplantation.
Scientific Title:Acronym High-dose intravenous immunoglobulin therapy for refractory viral infection after allogeneic hematopoietic stem cell transplantation.
Region
Japan

Condition
Condition Refractory viremia with high viral load, viral infection and viral disease after allogeneic hematopoietic stem cell transplantation
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the safety and efficacy of high-dose immunoglobulin therapy for refractory viral infection and disease.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cure rate of viremia and virus disease
Key secondary outcomes 1)Reduction of viral load
2)Degree of improvement in clinical symptoms, imaging findings and clinical laboratory test results

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 Intravenous immunoglobulin(400mg/kg/day) for 5 days.
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 Patients with hematological disease who received allogeneic hematopietic stem cell transplantation and meet the following criteria.
1) Ganciclovir or foscavir-resistant CMV infection or disease.
2) Aciclovir or valaciclovir-resistant HSV, VZV infection or disease.
3) Refractory adenovirus-associated hemorrhagic cystitis
4) Viral pneumonia
5) Viral gastroenteritis
6) Viral hepatitis
7) Viral encephalitis and meningitis
8) The following viremias with clinical symptom
[1]EBV
[2]HHV-6
[3]ADV
[4]Ganciclovir or foscavir-resistant CMV viremia
[5]Aciclovir or valaciclovir-resistant HSV, VZV viremia
[6]parvovirus B19
Key exclusion criteria 1) History of allergic reaction to immunoglobulin preparations
2) History of severe adverse effect of immunoglobulin preparations
3) Presence of veno-occlusive disease (VOD) after allogeneic stem cell transplantation
4) Positivity of HIV-antibody, HCV-antibody, HBs-antigen, or HBV-DNA
5) No indication for this study judged by physician in charge
Target sample size 14

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masayuki Hino
Organization Osaka City University, Graduate School of Medicine
Division name Hematology
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Email hinom@med.osaka-cu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mika Nakamae
Organization Osaka City University, Graduate School of Medicine
Division name Hematology(Clinical center for hematological malignancies )
Zip code
Address 1-4-3, Asahi-machi, Abeno-ku, Osaka, Japan. 545-8585
TEL 06-6645-3881
Homepage URL
Email crc-hematology@med.osaka-cu.ac.jp

Sponsor
Institute Hematology, Osaka City University, Graduate School of Meicine
Institute
Department

Funding Source
Organization None
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
2010 Year 01 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 Completed
Date of protocol fixation
2010 Year 01 Month 14 Day
Date of IRB
Anticipated trial start date
2010 Year 02 Month 19 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
2010 Year 01 Month 14 Day
Last modified on
2018 Year 12 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003475

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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