UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022415 |
|---|---|
| Receipt number | R000025733 |
| Scientific Title | Multicenter, open-label, non-controlled trial of short-term high dose dexamethasone therapy as initial treatment for idiopathic thrombocytopenic purpura |
| Date of disclosure of the study information | 2016/06/17 |
| Last modified on | 2017/05/09 10:08:27 |
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Basic information
Public title
Multicenter, open-label, non-controlled trial of short-term high dose dexamethasone therapy as initial treatment for idiopathic thrombocytopenic purpura
Acronym
NHOH-ITP-15
Scientific Title
Multicenter, open-label, non-controlled trial of short-term high dose dexamethasone therapy as initial treatment for idiopathic thrombocytopenic purpura
Scientific Title:Acronym
NHOH-ITP-15
Region
| Japan |
Condition
Condition
Idiopathic Thrombocytopenic Purpura
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In cases from 18-year-old 80-year-old of idiopathic thrombocytopenia, for patients whose platelet count less than 20,000 /mm^3 or less than 50,000 /mm^3 with bleeding symptoms, underwent short-term high dose dexamethasone therapy, its efficacy and safety.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Complete and partial response rate at 180 days from finish up dexamethasone pulse therapy.
Key secondary outcomes
Platelet count at 46+180 days.
Relapse free survival
Adverse event occurrence rate.
H,pyroli infection rate.
Therapeutic effect by eradication of H.pyroli.
Relapse free survival rate at 46+180days with or without H.pyroli infection.
Adverse event occurrence rate with or without eradication of H.pyroli.
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
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Multicenter, single-arm, open-label trial
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)age >18, <80
2)newly diagnosed untreated ITP adult patients
3)Platelet count<20*10^9/L
4)Platelet count>20*10^9/L and <50*10^9/L plus bleeding symptom.
5)PS 0 to 2
6)Patients received a fully described on the basis of informed consent document, by the free will of the person that consent is obtained in writing with respect to participation in the study.
In the case of minors, it is acceptable in the approval of the guardian
Key exclusion criteria
1)Active malignancy at time of study entry
2)Concomitant treatment with anti-platelet and or anti-coagulant drugs
3)Concomitant severe psychiatric disorders
4)Women who are pregnant or breastfeeding
5)Cardiovascular diseases requiring treatment
6)Severe non-controlled, despite therapy, hypertension and diabetes
7)Liver and kidney function impairment (creatinine, ALT, AST >2 times upper normal limit)
8)HCVAb, HIVAb, HBsAg seropositive status
9)Chronic liver disease
10)Documented viral illness by the positivity of IgM, or vaccination both occurred one month before diagnosis
11)Intake of drugs not previously taken within one week before diagnosis
12) Active gastric ulcer.
13)Severe intracranial bleeding or GI bleeding
14)Presence of autoimmune hemolytic anemia
15) Continuous administration of steroid hormone or immunosuppressive agents for other disease.
16)Not appropriate for this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ken Takase |
Organization
NATIONAL KYUSHU MEDICAL CENTER
Division name
Hematology
Zip code
Address
1-8-1,Jigyohama,Chuo-ku, Fukuoka-shi
TEL
092-852-0700
takase-k@kyumed.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari Egawa |
Organization
NATIONAL KYUSHU MEDICAL CENTER
Division name
Hematology
Zip code
Address
1-8-1,Jigyohama,Chuo-ku, Fukuoka-shi
TEL
092-852-0700
Homepage URL
mari@kyumed.jp
Sponsor or person
Institute
NATIONAL KYUSHU MEDICAL CENTER
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
| 2016 | Year | 06 | Month | 17 | 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
| 2016 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 23 | Day |
Last modified on
| 2017 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025733
