UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter, open-label, non-controlled trial of short-term high dose dexamethasone therapy as initial treatment for idiopathic thrombocytopenic purpura
Title of the study (Brief title)	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	Ken Takase
Organization	NATIONAL KYUSHU MEDICAL CENTER
Division name	Hematology
Address	1-8-1,Jigyohama,Chuo-ku, Fukuoka-shi
TEL	092-852-0700
Email	takase-k@kyumed.jp

Public contact
Name of contact person	Mari Egawa
Organization	NATIONAL KYUSHU MEDICAL CENTER
Division name	Hematology
Address	1-8-1,Jigyohama,Chuo-ku, Fukuoka-shi
TEL	092-852-0700
Homepage URL
Email	mari@kyumed.jp

Sponsor
Institute	NATIONAL KYUSHU MEDICAL CENTER
Institute
Department

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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 02 Month 04 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025733