UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003034 |
|---|---|
| Receipt number | 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 11:05:24 |
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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
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
crc-hematology@med.osaka-cu.ac.jp
Sponsor or person
Institute
Hematology, Osaka City University, Graduate School of Meicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003475
