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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011396
Receipt No. 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

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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/&#181;l) 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
Email

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
Email

Sponsor
Institute Hematology/ Oncology, Iwate Medical University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013242

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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