Prednisone or Dexamethasone in Newly Diagnosed, Previously Untreated Primary Immune Thrombocytopenic Purpura
NCT00657410 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 150
Last updated 2017-02-20
Summary
RATIONALE: Drugs, such as prednisone and dexamethasone, may change the immune system and be an effective treatment for primary immune thrombocytopenic purpura. It is not yet known which drug is more effective in treating primary immune thrombocytopenic purpura.
PURPOSE: This randomized phase III trial is studying high-dose dexamethasone to see how well it works compared to standard-dose prednisone in treating patients with newly diagnosed, previously untreated primary immune thrombocytopenic purpura.
Conditions
- Nonneoplastic Condition
Interventions
- DRUG
- DRUG
- PROCEDURE
-
quality-of-life assessment
Sponsors & Collaborators
-
Gruppo Italiano Malattie EMatologiche dell'Adulto
lead OTHER
Principal Investigators
-
Maria Gabriella Mazzucconi, MD · Gruppo Italiano Malattie EMatologiche dell'Adulto
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2016-02-29
- Completion
- 2016-02-29
Countries
- Italy
Study Locations
More Related Trials
-
Initial Treatment of Patients With Immune Thrombocytopenic Purpura
NCT00991939 ·Status: TERMINATED ·Phase: PHASE3
-
Comparison Between Methyl Prednisolone and Intravenous Dexamethazone in Severe Immune Thrombocytopenic Purpra
NCT03183284 ·Status: UNKNOWN
-
The Efficacy of Dexamethasone Versus Dexamethasone Combined With Rituximab in Patients With Newly Diagnosed Idiopathic Thrombocytopenic Purpura (ITP)
NCT00909077 ·Status: COMPLETED ·Phase: PHASE3
-
High-dose Dexamethasone Plus Hetrombopag vs High-dose Dexamethasone Alone as Frontline Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Prospective, Multicenter, Randomized Trial
NCT05943691 ·Status: UNKNOWN ·Phase: PHASE2
-
Short-course High-dose Prednisone and Dexamethasone in Children With ITP
NCT05522465 ·Status: RECRUITING ·Phase: PHASE4
-
rhTPO Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of ITP
NCT01734044 ·Status: COMPLETED ·Phase: PHASE3
-
Different Cycles of High-dose Dexamethasone for Initial Management of Primary Immune Thrombocytopenia (ITP)
NCT02642380 ·Status: WITHDRAWN ·Phase: PHASE4
-
Decitabine Combining Dexamethasone Versus Dexamethasone in Management of ITP
NCT03252457 ·Status: UNKNOWN ·Phase: PHASE3
-
Teriflunomide Plus High-dose Dexamethasone as First-line Treatment in Newly Diagnosed Primary Immune Thrombocytopenia
NCT06176235 ·Status: WITHDRAWN ·Phase: PHASE2
-
An Investigation of Dexamethasone With Different Doses in the Management of Immune Thrombocytopenia (ITP)
NCT02153060 ·Status: COMPLETED ·Phase: PHASE2
-
Eltrombopag and High-dose Dexamethasone as First Line Treatment for IT
NCT01652599 ·Status: COMPLETED ·Phase: PHASE2
-
A Study of Romiplostim N01 as the First-line Treatment for Newly Diagnosed Adult Patients With ITP
NCT06658834 ·Status: RECRUITING ·Phase: PHASE2
-
A Multicenter Randomized Open-label Study of Diammonium Glycyrrhizinate Enteric-coated Capsule Plus DXM Versus DXM in Treatment of ITP
NCT05023915 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Glycyrrhetinic Acid Combined With Dexamethasone in Management of Newly Diagnosed ITP
NCT03998982 ·Status: UNKNOWN ·Phase: PHASE4
-
Safety and Efficacy of Eltrombopag Plus Pulsed Dexamethasone for Subjects With Idiopathic Thrombocytopenic Purpura
NCT03830749 ·Status: COMPLETED ·Phase: PHASE2
-
Efficacy and Safety of DAPSone as a Second-line Option in Adult Immune Thrombocytopenia
NCT02627417 ·Status: UNKNOWN ·Phase: PHASE3
-
All-Trans Retinoic Acid (ATRA) Combining Dexamethasone Versus High-dose Dexamethasone for Initial Treatment of Primary Immune Thrombocytopenia (ITP)
NCT01882127 ·Status: WITHDRAWN ·Phase: PHASE3
-
The Combination of ATRA and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia
NCT04217148 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Assess Efficacy and Safety of Eltrombopag in Combination With a Short Course of Dexamethasone in Patients With Newly Diagnosed ITP
NCT04346654 ·Status: COMPLETED ·Phase: PHASE2
-
IgIV Plus Prednisone vs High-dose Dexamethasone for ITP
NCT04968899 ·Status: RECRUITING ·Phase: PHASE3
-
The Efficacy and Safety of Combined Teriflunomide and High-dose Dexamethasone in Newly Diagnosed Primary Immune Thrombocytopenia (TEMPO-2)
NCT07065968 ·Status: RECRUITING ·Phase: PHASE2
-
A Study Evaluating the Addition of MabThera (Rituximab) to Standard Treatment in Patients With Idiopathic Thrombocytopenic Purpura (ITP)
NCT00770562 ·Status: COMPLETED ·Phase: PHASE3
-
The Combination of Tacrolimus and High-dose Dexamethasone as First-line Treatment in Adult Immune Thrombocytopenia
NCT04747080 ·Status: UNKNOWN ·Phase: PHASE2
-
Low-dose Rituximab and High-dose Dexamethasone as First Line Treatment for ITP
NCT01107951 ·Status: COMPLETED ·Phase: PHASE2
-
Romiplostim N01 Combined With Glucocorticoids as the First-line Treatment for Newly Diagnosed Adult Primary Immune Thrombocytopenia: A Multicenter, Interventional Trial
NCT06992128 ·Status: RECRUITING ·Phase: PHASE2