UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011134 |
|---|---|
| Receipt number | R000013015 |
| Scientific Title | A prospective randomized dose comparison multicenter study of the rabbit anti-thymocyte globulin (thymoglobulin, Genzyme) for patients with severe and very severe aplastic anemia |
| Date of disclosure of the study information | 2013/07/08 |
| Last modified on | 2019/07/15 14:15:31 |
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Basic information
Public title
A prospective randomized dose comparison multicenter study of the rabbit anti-thymocyte globulin (thymoglobulin, Genzyme) for patients with severe and very severe aplastic anemia
Acronym
APBMT AAWG-01
Scientific Title
A prospective randomized dose comparison multicenter study of the rabbit anti-thymocyte globulin (thymoglobulin, Genzyme) for patients with severe and very severe aplastic anemia
Scientific Title:Acronym
APBMT AAWG-01
Region
| Japan | Asia(except Japan) |
Condition
Condition
Acquired Aplastic Anemia
Classification by specialty
| Hematology and clinical oncology | Pediatrics | Adult |
| Child |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
The objective of this study is to evaluate the feasibility and effectiveness of immunosuppressive therapy (IST) using rabbit anti-thymocyte globulin (ATG) (Thymoglobuline, Genzyme) for patients with very severe aplastic anemia (VSAA) and severe aplastic anemia (SAA) as a primary therapy.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the response rate (complete response (CR) + partial response (PR)) at day 180 after the start of IST.
Key secondary outcomes
Secondary endpoints include evaluation of the presence and frequency of Epstein-Barr virus (EBV)-reactivation and EBV-associated lymphoproliferative disorder (EBV-LPD), Cytomegalovirus(CMV)-reactivation and CMV associated diseases, the response rate (CR+PR) on Day 360 after the start of IST, relapse rate and overall survival.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
2.5 mg/kg/day of Thymoglobulin for 5 days
Interventions/Control_2
3.5 mg/kg/day of Thymoglobulin for 5 days
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Acquired aplastic anemia
Age: younger than 70 years old
Severity: SAA, VSAA.
Interval between diagnosis and registration <6 months.
Written informed consent from the caretakers and/or whenever possible consent from the patient.
Key exclusion criteria
None
Target sample size
320
Research contact person
Name of lead principal investigator
| 1st name | Seiji |
| Middle name | |
| Last name | Kojima |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
466-8560
Address
65, tsuruma-cho, showa-ku, Nagoya
TEL
052-744-2294
kojimas@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Muramatsu |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Pediatrics
Zip code
466-8560
Address
65, tsurumai-cho, showa-ku, Nagoya
TEL
052-744-2294
Homepage URL
hideki-muramatsu@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Center for Advanced Medicine and Clinical Research
Address
65, tsurumai-cho, showa-ku, Nagoya
Tel
052-744-1958
center@med.nagoya-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
NCT01844635
Org. issuing International ID_1
NIH
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/31206607
Number of participants that the trial has enrolled
222
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
Main results already published
Date of protocol fixation
| 2012 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2012 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2022 | 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
| 2013 | Year | 07 | Month | 06 | Day |
Last modified on
| 2019 | Year | 07 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013015
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
