Triple therapy for primary immune thrombocytopenia

• Conditions: Primary immune thrombocytopenia; Blood - Haematological diseases

• Registration Number: ACTRN12611000015943
• Lead Sponsor: Professor Beng Hock Chong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-01-06
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Primary ITP as diagnosed according to IWG guidelines (Provan et, 2010)
Platelet count <30x10^9/L or 30-50x10^9/L with either 1. evidence of ongoing bleeding secondary to thrombocytopenia or 2. treatment dependence including corticosteroids, IVIG, second-line immunosuppressants and TPO-agonists.
Fully informed written consent

Exclusion Criteria

Treatment in the last 6 months with combination therapy of high dose corticosteroids (methylprednisolone >30mg/kg/day for 3 days or high dose dexamethasone 40mg/day for 4 days) and either anti-CD 20 antibody (rituximab) or anti-T cell therapy with cyclosporine or mycophenolate mofetil
Active malignant disease - except BCC or SCC of skin
Untreated hepatitis B infection
Active opportunistic infection or untreated tuberculosis
Life expectancy of less than 12 months
Moderate-severe renal impairment (eGFR<50mL/min)
Poorly controlled hypertension (BP>140/80)
Pregnancy in females of child-bearing age

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Response rate (platelet count >30x10^9/L, at least 2 fold increase in baseline platelet count and absence of bleeding)[6 months];Complete response rate (platelet count >100x10^9/L, at least 2 fold increase in platelet count and absence of bleeding)[6 months]