Health Condition 1: null- Chronic Immune thrombocytopenic purpura
Conditions
Interventions
Intervention1: AZATHIOPRINE,
Dose: 1-3mg/kg/day for 6 months: Patients with ITP that are steroid refractory or steroid relapsing will be randomized to receive either dapsone or azathioprine. Those who
Sponsors
Institution sponsored
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: Patients diagnosed to have ITP (confirmed on bone marrow examination), who meet the following criteria: Steroid refractory ITP - Defined as platelet count Steroid dependent ITP: Defined as initial response to steroid therapy (Partial or complete) with recurrence of severe thrombocytopenia ( <30,000/mm3) upon taper of steroids.
Exclusion criteria
Exclusion criteria: 1)Secondary ITP â?? Other known autoimmune disorder (Rheumatoid arthritis, SLE, Hypothyroidism), Drugs, HIV, Pregnancy 2)Known G6PD deficiency 3)ITP with life-threatening bleeds â?? IC bleeds, GI bleeds.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1.Relapse rates after taper of drugs Partial relapse (50% decrease in platelet count from value at initiation of taper) Complete relapse (Platelet count 30,000/mm3) 2.Time to response (Months) Time to partial response Time to complete response 3.Incidence of Toxicity â?? Short term ( 6 months) and Long term (period of Rx) Yes/No SPECIFY: RASH/HEMOLYSIS/NEUROPATHY/CYTOPENIA Necessitated dose reduction Yes/No Necessitated drug discontinuation Yes/NoTimepoint: 6 months | — |
Primary
| Measure | Time frame |
|---|---|
| Response to therapy at 6 months â?? defined as Complete response: Platelet count 1,00,000/mm3 Partial response: Doubling of baseline platelet count and platelet count 30,000/mm3 No response: Platelet count 30,000/mm3Timepoint: At 6 months | — |
Countries
India
Contacts
Public ContactDr Anu Korula
Christian Medical College, Vellore
Outcome results
None listed