Idiopathic thrombocytopenic purpura, Thrombocytopenia, Immune Thrombocytopenia, Azathioprine, Sirolimus. Immune thrombocytopenic purpura
Conditions
Interventions
Intervention 1: Intervention group 1: Intervention group will receive oral Sirolimus dosing that depends on body weight: children over 40 kg will receive 6 mg/m² on day one, then 2 mg/m² daily
those under 40 kg will receive 3 mg/m² initially, followed by 1 mg/m² daily. All patients will receive low-dose prednisolone at 0.5 mg/kg/day (maximum 5 mg/day). If gastrointestinal discomfort occurs,
Sponsors
Boushehr University of Medical Sciences
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Inclusion criteria
Inclusion criteria: Children aged 5–18 with ITP >1 year Platelets <30,000/µL No splenectomy or other blood disorders Parental consent was obtained
Exclusion criteria
Exclusion criteria: Patients who have active infection Anaphylactic shock occurs following drug intake If the direct or indirect Coombs test is positive Renal failure (raised BUN, Cr) or GFR less than 50 mL/min/1.73 m² History of seizure Inability to tolerate oral therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Platelet counts. Timepoint: Platelet counts will measure at baseline and monthly for six months. Method of measurement: The number of platelets is measured by using the Cell Counter Sysmax device. Complete response: platelet count >100,000/µL. Partial response: platelet count 30,000–100,000/µL with at least a twofold increase from baseline. No response: platelet count <30,000/µL or less than a twofold increase from baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Bleeding severity. Timepoint: At baseline and after 6 months. Method of measurement: Bleeding severity is classified as severe (requiring hospitalization), moderate (requiring medication), or mild (such as petechiae and purpura that resolve spontaneously). | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNader Shakibazad
Boushehr University of Medical Sciences
Outcome results
None listed