UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011396 |
|---|---|
| Receipt number | R000013242 |
| Scientific Title | Eltrombopag treatment for dose-reduction of corticosteroid in corticosteroid dependent adult chronic immune thrombocytopenia (ITP) patients. |
| Date of disclosure of the study information | 2013/08/10 |
| Last modified on | 2013/08/07 01:54:05 |
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Basic information
Public title
Eltrombopag treatment for dose-reduction of corticosteroid in corticosteroid dependent adult chronic immune thrombocytopenia (ITP) patients.
Acronym
Eltrombopag treatment for dose-reduction of corticosteroid in corticosteroid dependent adult chronic immune thrombocytopenia (ITP) patients.
Scientific Title
Eltrombopag treatment for dose-reduction of corticosteroid in corticosteroid dependent adult chronic immune thrombocytopenia (ITP) patients.
Scientific Title:Acronym
Eltrombopag treatment for dose-reduction of corticosteroid in corticosteroid dependent adult chronic immune thrombocytopenia (ITP) patients.
Region
| Japan |
Condition
Condition
Corticosteroid Dependent Adult Chronic Immune Thrombocytopenia
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess dose reduction procedure of corticosteroid by the addition of eltrombopag in corticosteroid dependent chronic adult ITP patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of patients who can replace prednisolone with eltrombopag
Key secondary outcomes
Base
Study type
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
Eltrombopag 12.5mg to 50mg
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
Male and Female
Key inclusion criteria
1. Adult (over than 20 years old) chronic ITP patients
(<10x104/µl) under the treatment of corticosteroid
2. One of the followings
A. Corticosteroid dependent (refractory)
B. Strong request of patient for discontinuation
of corticosteroid treatment
C. Any medical reason for difficulty of continuation
of corticosteroid treatment
3. Negative anti-phospholipid antibody
4. Obtainable written informed consent
Key exclusion criteria
1. Any history of thrombo-embolic events.
2. Any hereditary disorder that may cause thrombo-
embolic events such as ATIII deficiency or Protein
C/S deficiency.
3. Any history of allergy/ intolerance to the study drug.
4. Pregnant, possibly pregnant and lactating women as
well as women who intend to become pregnant
within the proposed study period.
5. Any concomitant drugs or therapy that may
influence the result of the study.
6. Renal or hepatic dysfunction/insufficiency.
7. HIV infection, HBV infection
7. Subjects judged as unsuitable for participation in
the study for any reason by the physicians in charge
of the study.
8. Unable to participate all sessions of the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Ishida |
Organization
Iwate Medical University
Division name
Hematology/ Oncology
Zip code
Address
19-1, Uchimaru, Morioka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Iwate Medical University
Division name
Hematology/ Oncology
Zip code
Address
19-1, Uchimaru, Morioka
TEL
Homepage URL
Sponsor or person
Institute
Hematology/ Oncology, Iwate Medical University
Institute
Department
Personal name
Funding Source
Organization
GlaxoSmithKline K.K.
Organization
Division
Category of Funding Organization
Profit organization
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
| 2013 | Year | 08 | Month | 10 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | 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
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2013 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013242
| 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 |
