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

JRCT ID: jRCTs041190069

Registered date:25/09/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Chronic Idiopathic Thrombocytopenic Purpura
• Date of first enrollment: 01/10/2019
• Target sample size: 7
• Study type: Interventional
• Intervention(s): Administration of dexamethasone palmitate (5mg/day for 4 days)

Outcome(s)

Primary Outcome

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

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 75age old
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Nakayama Takayuki