Immune Thrombocytopenia Clinical Trial
Official title:
A Multicenter Prospective Randomized Study of Dexamethasone Combined With Decitabine Versus Dexamethasone in the Treatment of Newly Diagnosed Primary Immune Thrombocytopenia (ITP)
The project was undertaking by Qilu Hospital of Shandong University and other 18 well-known hospitals in China. In order to report the efficacy and safety of decitabine combining with dexamethasone for the treatment of adults with immune thrombocytopenia (ITP), compared to dexamethasone alone .
The investigators anticipate to undertaking a parallel group, multicentre, randomised controlled trial of 200 ITP adult patients from 19 medical centers in China. One part of the participants are randomly selected to receive dexamethasone (given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given) combining with decitabine (given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3 cycles), the others are selected to receive dexamethasone therapy(given 40mg/d for 4 consecutive days as a cycle, If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given). Platelet count, bleeding and other symptoms were evaluated before and after treatment, adverse events are also recorded throughout the study in order to report the efficacy and safety of the combination therapy compared to dexemathasone alone therapy for the treatment of adults with ITP. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02287649 -
Polymorphism and Auto-reactive B and T Cells Subsets in Adult's Immune Thrombocytopenia (ITP)
|
N/A | |
| Terminated |
NCT02401061 -
PRTX-100-202 Open-Label, Dose Escalation Study in Adult Patients With ITP
|
Phase 1/Phase 2 | |
| Completed |
NCT02556814 -
Caffeic Acid Combining High-dose Dexamethasone in Management of ITP
|
Phase 4 | |
| Completed |
NCT02868099 -
Efficacy and Safety of Romiplostim in Adult Subjects With Persistent or Chronic Immune Thrombocytopenia (ITP)
|
Phase 3 | |
| Completed |
NCT02351622 -
Caffeic Acid Tablets as a Second-line Therapy for ITP
|
Phase 3 | |
| Active, not recruiting |
NCT04741139 -
Post IVIG Medication in Children With Immune Thrombocytopenia
|
Phase 1 | |
| Not yet recruiting |
NCT05468866 -
The Expression of Immune Checkpoint CD28 rs1980422-related Single-nucleotide Polymorphisms in the Primary Immune Thrombocytopenia
|
N/A | |
| Not yet recruiting |
NCT05494307 -
The Combination of Terbutaline and Danazol as the Treatment of Corticosteroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
| Recruiting |
NCT05281068 -
The Combination of Iguratimod and Danazol as the Treatment of Steroid-resistant/Relapse Immune Thrombocytopenia
|
Phase 2 | |
| Recruiting |
NCT04993885 -
Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies
|
Phase 2 | |
| Not yet recruiting |
NCT05020288 -
A Clinical Trial of the Orelabrutinib in the Management of Refractory ITP
|
Phase 2 | |
| Withdrawn |
NCT03965624 -
Efficacy and Safety of Ixazomib and Dexamethasone Refractory Autoimmune Cytopenia
|
Phase 2 | |
| Recruiting |
NCT05937828 -
OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
|
||
| Completed |
NCT03156452 -
Newly Diagnosed Immune Thrombocytopenia Testing the Standard Steroid Treatment Against Combined Steroid & Mycophenolate
|
Phase 3 | |
| Completed |
NCT03164915 -
A Clinical Study to Evaluate the Efficacy and Safety of LIV-GAMMA SN Inj. in Primary Immune Thrombocytopenia (ITP)
|
Phase 3 | |
| Recruiting |
NCT02270801 -
Recombinant Human Thrombopoietin (rhTPO) in Management of Immune Thrombocytopenia (ITP) in Pregnancy
|
Phase 3 | |
| Completed |
NCT01933035 -
Extended Platelet Parameters as a Means to Differentiate Immune Thrombocytopenia From Hypo-proliferative Thrombocytopenias.
|
N/A | |
| Withdrawn |
NCT01976195 -
High-dose Dexamethasone Combining Thalidomide Versus Dexamethasone Mono-therapy for Management of Newly-diagnosed ITP
|
Phase 2 | |
| Recruiting |
NCT02821572 -
Role of Fcgamma Receptors in Immune Thrombocytopenia (ITP)
|
||
| Not yet recruiting |
NCT05562882 -
A Clinical Trial to Assess Safety and Efficacy of Daratumumab in the Treatment of Primary Immune Thrombocytopenia
|
Early Phase 1 |