Clinical study to evaluate the efficacy of dexamethasone Palmitate for idiopathic (immune) thrombocytopenic purpura: ITP.

• Register: JPRN
• Last refreshed on: 22 January 2024
• Main ID: JPRN-jRCTs041190069
• Date of registration: 25/09/2019
• Prospective Registration: Yes
• Primary sponsor: Nakayama Takayuki
• Public title: Clinical study to evaluate the efficacy of dexamethasone Palmitate for idiopathic (immune) thrombocytopenic purpura: ITP.
• Scientific title: Clinical Investigation to evaluate the efficacy of dexamethasone palmitate for idiopathic (immune) thrombocytopenic purpura: ITP. - Clinical investigation of Dexamethasone Palmitate for ITP
• Date of first enrolment: 01/10/2019
• Target sample size: 7
• Recruitment status: Complete
• URL: https://jrct.niph.go.jp/latest-detail/jRCTs041190069
• Study type: Interventional
• Study design: single arm study, open(masking not used), active control, parallel assignment, treatment purpose
• Phase: 1

Contacts

• Name: Takayuki Nakayama
• Affiliation: Aichi Medical University Hospital

• Name: Kaori Uchino
• Affiliation: Aichi Medical University Hospital

Key inclusion & exclusion criteria

Inclusion criteria: Patients with thrombocytopenia (platelet count <30*10(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 30*10(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
Age maximum: <= 75age old
Gender: Both

Health Condition(s) or Problem(s) studied

Chronic Idiopathic Thrombocytopenic Purpura
refractory, immune, thrombocytopenia,

D016553

Intervention(s)

Administration of dexamethasone palmitate (5mg/day for 4 days)

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

Ethics review

Status: Approval
Approval date:
Contact:

[e-mail]

Certified Clinical Research Review Board of Aichi Medical University Hospital

[phone]

[e-mail]

Results

• Results available: Yes
• Date Posted: 30/11/2023
• Date Completed: 31/12/2022