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High-dose Dexamethasone Cycles in Primary ITP
NCT02642380Phase 4
Key facts
- Status
- Withdrawn
- Start
- Nov 2015
- Primary completion
- Nov 2018
- Countries
- 1
- Sponsor
- Shandong University
- Modality
- Orthosteric Ligands
- Drugs
- dexamethasone
- Conditions
- immune thrombocytopenia (ITP)
01
Overview
Phase 4, randomised, open-label trial of dexamethasone in immune thrombocytopenia (ITP) (2 arms), sponsored by Shandong University. Primary endpoint: Sustained response to treatment at 6 months. Planned start Nov 2015; status: withdrawn.
02
Design
2 arms- Study design
- RandomizedOpen-label
4 cycles
Dexamethasone 40mg/day for 4 days every 14 days x 4 cycles
1 cycle
Dexamethasone 40mg/day for 4 days x 1 cycle
03
Endpoints
Primary
Sustained response to treatment
Secondary
Evaluation of early response
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