臨床研究等提出・公開システム

Japanese

Date of registration	Sept. 25, 2019
Last modified on	Nov. 30, 2023
Trial ID	jRCTs041190069

Scientific Title	Clinical Investigation to evaluate the efficacy of dexamethasone palmitate for idiopathic (immune) thrombocytopenic purpura: ITP. (Clinical investigation of Dexamethasone Palmitate for ITP)
Public Title	Clinical study to evaluate the efficacy of dexamethasone Palmitate for idiopathic (immune) thrombocytopenic purpura: ITP. (Clinical study of Dexamethasone Palmitate for ITP)

Completion date	Dec. 31, 2022
Result actual enrolment	0
Baseline Characteristics	Patients with thrombocytopenia (platelet count <3010(9) /L) in spite of treatment-line for ITP for more than 6 months. Patients with symptoms of ITP althouth theit platelet count is more than 3010(9) /L. Patients who are difficult to continue their present treatment-line for ITP due to theside effects.
Participant flow	N/A due to no registration
Adverse events	N/A due to no registration
Outcome measures	N/A due to no registration
Brief summary	N/A due to no registration
Date of posting of results summaries	Nov. 30, 2023
Date of the first journal publication of results
URL hyperlink(s) related to results and publications

Plan to share IPD	No
Plan description	N/A due to no registration
URL link to protocol file(s) with version and date	https://jrct.mhlw.go.jp/latest-detail/jRCTs041190069

Contact for Scientific Queries	Name	Nakayama Takayuki
	Affiliation	Aichi Medical University Hospital
	Address	1-1, Yazakokarimata, Nagakute, Aichi, Japan
	Telephone	+81-561-62-3311
	E-mail	tnaka@med.nagoya-u.ac.jp
Contact for Public Queries	Name	Uchino Kaori
	Affiliation	Aichi Medical University Hospital
	Address	1-1, Yazakokarimata, Nagakute, Aichi, Japan
	Telephone	+81-561-62-3311
	E-mail	ksakai@aichi-med-u.ac.jp

Recruitment status	Complete

Anticipated date of first enrollment		Oct. 01, 2019
Actual date of first enrollment
Target sample size		7
Study Type		Interventional
Study Design	allocation	single arm study
	masking	open(masking not used)
	control	active control
	assignment	parallel assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with thrombocytopenia (platelet count <3010(9) /L) although in spite of treatment-line for ITP for more than 6 months. Patients with symptoms of ITP althouth theit platelet count is more than 3010(9) /L. Patients who are difficult to continue their present treatment-line for ITP due to theside effects. Patients with agreements with the documents of this study.
	Exclusion Criteria	Patients with severe drug allergy Patients with severe kidney failure(Ccr<30mL/min) Patients with treatment-resistant diabetes(HbA1c>7.5) Patients with active infection Patients with mental illness Patients with gustric ulcer Pregnancy, breastfeeding or patients with possibility of pregnancy Patients with liver dysfunction(at least 1 criterion: AST>100 IU/L,ALT>100 IU/L,T.Bil>2 mg/dL) High stature(hight>190cm), short stature(hight<145cm), Severe obesity(BMI:body mass index>30) Severe emaciation(BMI<16) Cases that cannot obtain sufficient information or data due to short life spans expected by severe illness other than ITP. Other conditions considered not suitable for the study by doctors.
	Age Minimum	20age old over
	Age Maximum	75age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Chronic Idiopathic Thrombocytopenic Purpura
Intervention(s)		Administration of dexamethasone palmitate (5mg/day for 4 days)
Health Condition(s) Keyword		refractory, immune, thrombocytopenia,
Intervention(s) Keyword		Dexamethasone palmitate
Health Condition(s) Code		D016553
Intervention(s) Code		C035081
Primary Outcome(s)		Symptoms of bleeding Complete blood count and the results of coagulations parameters(Platelet, FDP, Fibrinogen, PT-INR, TAT,Soluble fibrin, PIC, D-dimer): before start of medication, after one week of medication, after three weeks of medication, after six weeks of medication, after ten weeks of medication, after eighteen weeks of medication, and after one year of medication Changing of present treatment of ITP Outcome of the patatients
Secondary Outcome(s)		Safety of Dexamethasone palmitate for patients with chronic ITP. Adverse event 1. Increased risk of an infection 2. Changes in blood sugar levels 3. Swollen hands and feet 4. Mood changes 5. Difficulty sleeping 6. Indigestion or heartburn 7. Increased appetite and weight gain 8. Osteoporosis

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	Certified Clinical Research Review Board of Aichi Medical University Hospital
Address	1-1,Yazakokarimata, Nagakute, Aichi, Japan, Aichi
Telephone	+81-561-62-3311
E-Mail	amu_crb@aichi-med-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 05, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

No	Publication date
3	Nov. 30, 2023	(this page)	Changes
2	June. 02, 2021	Detail	Changes
1	Sept. 25, 2019	Detail

List of change history