Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
Recombinant Human Thrombopoietin in Combination With Rituximab Versus Low-dose Rituximab for the Treatment of Refractory ITP.
The project was undertaking by Qilu Hospital of Shandong University and other 13 well-known hospitals in China. In order to report the efficacy and safety of Recombinant Human thrombopoietin combining with Rituximab for the treatment of adults with refractory immune thrombocytopenia (ITP), compared to conventional Rituximab therapy.
The investigators are undertaking a parallel group, multicentre, randomised controlled trial of 240 refractory ITP adult patients from 14 medical centers in China. One part of the participants are randomly selected to receive recombinant human thrombopoietin (given subcutaneously at a dose of 300 Units/kg for 14 consecutive days,following with a flexible dosage depending on platelet count until the 29th day), combining with rituximab (given intravenously at a dose of 100 mg weekly for 4 weeks, i.e. Day 1, 8, 15, 22; the others are selected to receive low-dose of rituximab treatment (given intravenously at a dose of 100 mg weekly, i.e. Day 1, 8, 15, 22). 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 conventional rituximab therapy for the treatment of adults with refractory ITP. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05220878 -
Comparative Study of Clinical Efficacy and Safety of GNR-069 and Nplate in Patients With ITP
|
Phase 3 | |
| Completed |
NCT00451594 -
High Dose Dexamethasone Vs. Conventional Dose Prednisolone in Adult ITP
|
Phase 3 | |
| Withdrawn |
NCT01276561 -
Single Incision Versus Standard Laparoscopic Splenectomy
|
N/A | |
| Completed |
NCT01713855 -
Vaccine Response After Rituximab for Chronic, Severe Idiopathic Thrombocytopenic Purpura
|
N/A | |
| Recruiting |
NCT03465020 -
Investigation on a Dynamic Cohort of Italian Patients With Active ITP
|
||
| Completed |
NCT00603642 -
P3 Study to Evaluate Efficacy and Safety of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura
|
Phase 3 | |
| Completed |
NCT01143038 -
Interventional Study in Adults With Immune Thrombocytopenia Purpura (ITP) Receiving Romiplostim
|
Phase 2 | |
| Not yet recruiting |
NCT04128358 -
Triple Therapy in Patients With Idiopathic Thrombocytopenic Purpura : What is Behind?
|
N/A | |
| Completed |
NCT00128882 -
Treatment of Idiopathic Thrombocytopenic Purpura (ITP) With Subcutaneously Administered Anti-D
|
Phase 2 | |
| Completed |
NCT00888901 -
Platelet Function in Idiopathic Thrombocytopenic Purpura (ITP) Patients With Eltrombopag
|
Phase 4 | |
| Completed |
NCT00828750 -
Clinical Evaluation of Eltrombopag in Chronic Idiopathic Thrombocytopenic Purpura (ITP)
|
Phase 3 | |
| Completed |
NCT00475423 -
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
|
Phase 2 | |
| Completed |
NCT00625443 -
Phase 2, Parallel Group, Rollover Study of AKR-501 in Patients With ChronicITP Who Completed 28 Days of Study Treatment in Protocol 501-CL-003
|
Phase 2 | |
| Completed |
NCT00454857 -
Retrospective & Prospective Observational Study of Patients With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)
|
N/A | |
| Completed |
NCT00102323 -
AMG 531 Treatment of Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) Refractory to Splenectomy
|
Phase 3 | |
| Completed |
NCT05492409 -
Study of the Safety and Immunogenicity of Long-term GNR-069 Therapy in ITP Patients
|
Phase 3 | |
| Terminated |
NCT01433978 -
A Phase 3, Multicenter, Randomized, Double-blind,Active-controlled, Parallel-group Trial With an Open-labelExtension Phase to Evaluate the Efficacy and Safety of OralE5501 Versus Eltrombopag, in Adults With Chronic ImmuneThrombocytopenia (Idiopathic Thrombocytopenic Purpura)
|
Phase 3 | |
| Withdrawn |
NCT01443351 -
Long-term Safety Study of Treatment With the Thrombopoietin Agonists Eltrombopag and Romiplostim in Patients With Immune Thrombocytopenia (ITP)
|
||
| Completed |
NCT01520909 -
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body.
|
Phase 3 | |
| Not yet recruiting |
NCT06287567 -
Lusutrombopag in the Treatment of Immune Thrombocytopenia (ITP)
|
Phase 4 |