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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCTs041190069

Enrollment

Registered

2019-09-25

Start date

2019-10-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Idiopathic Thrombocytopenic Purpura refractory, immune, thrombocytopenia,

Interventions

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

C035081

Dexamethasone palmitate

Eligibility

Sex/Gender

All

Inclusion 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

Exclusion criteria: Patients with severe drug allergy Patients with severe kidney failure(Ccr7.5) 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(hight30) 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.

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

Measure	Time frame
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	—

Contacts

Public ContactKaori Uchino

Aichi Medical University Hospital

ksakai@aichi-med-u.ac.jp+81-561-62-3311

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026