Phase 3
N=26
Daily Prednisone Versus Pulsed Dexamethasone in Treatment-naïve Adult Patients With Immune Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Bottom Line
View on ClinicalTrials.gov: NCT02334813 ↗Enrolled (actual)
26
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Remission Duration — 3; 11 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Prednisone (Drug); Dexamethasone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospital, Essen
- Primary completion
- Jan 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Remission Duration |
3; 11 | — |
Summary
Patients above age 18 with a first episode of immune thrombocytopenia are randomized 1:1 between 2-4 weeks of daily prednisone (1 mg/kg/d) with subsequent dose tapering (arm A) and six 3-week cycles of pulsed dexamethasone (0.6 mg/kg/d, days 1-4; arm B). The primary endpoint is duration of remission defined as platelets ≥50/nl.
Eligibility Criteria
Inclusion Criteria
- First episode of ITP
Exclusion Criteria
- Pregnancy
- Glucocorticoid intolerance
Data sourced from ClinicalTrials.gov (NCT02334813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.