Efficacy of Dapsone and Azathioprine in patients with chronic IPT.
Not Applicable
- Conditions
- Health Condition 1: null- Chronic Immune thrombocytopenic purpura
- Registration Number
- CTRI/2016/02/006652
- Lead Sponsor
- Institution sponsored
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 500
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 <30,000/mm3 after standard steroid therapy (Prednisolone 1mg/kg for 1 month) or High dose Dexamethasone (40mg OD for 4 days)
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response to therapy at 6 months â?? defined as <br/ ><br>Complete response: Platelet count 1,00,000/mm3 <br/ ><br>Partial response: Doubling of baseline platelet count and platelet count 30,000/mm3 <br/ ><br>No response: Platelet count 30,000/mm3Timepoint: At 6 months
- Secondary Outcome Measures
Name Time Method 1.Relapse rates after taper of drugs Partial relapse (50% decrease in platelet count from value at initiation of taper) <br/ ><br>Complete relapse (Platelet count 30,000/mm3) <br/ ><br>2.Time to response (Months) <br/ ><br>Time to partial response <br/ ><br>Time to complete response <br/ ><br>3.Incidence of Toxicity â?? Short term ( 6 months) and Long term (period of Rx) <br/ ><br>Yes/No SPECIFY: RASH/HEMOLYSIS/NEUROPATHY/CYTOPENIA <br/ ><br>Necessitated dose reduction Yes/No <br/ ><br>Necessitated drug discontinuation Yes/NoTimepoint: 6 months