Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
A Phase 2 Interventional Single Arm Study Describing Platelet Responses and ITP Remission Rates in Adult Subjects With Immune Thrombocytopenia Purpura Receiving Romiplostim
The purpose of this study is to describe the number of months with a platelet response over a 12 month treatment period and to describe ITP remission rates in adults with ITP receiving romiplostim.
The study includes a 4-week screening period, a 12-month romiplostim treatment period, and a romiplostim dose-tapering period. During the 12-month treatment period romiplostim doses could be increased or decreased to maintain a platelet count between ≥ 50 x 10^9/L and ≤ 200 x 10^9/L. Participants who dose reduce such that they no longer require treatment with romiplostim during the 12-month treatment period will continue with all required study procedures up to 12 months and will be monitored for ITP remission for at least 6 months. At the completion of the 12-month treatment period, participants receiving only romiplostim and with a platelet count ≥ 50 x 10^9/L will enter the tapering period, during which the romiplostim dose will be decreased by 1 µg/kg every 2 weeks, for up to 19 weeks. If a participant maintains a platelet count of ≥ 50 x 10^9/L in the absence of romiplostim and all medications for ITP (concomitant or rescue), the participant will be followed for at least 6 months to confirm the incidence of ITP remission. If a participant's platelet count falls below 50 x 10^9/L and the participant has tapered off treatment with romiplostim, the participant will enter the stabilization period and reinitiate romiplostim for up to 8 weeks. ;
| 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| Withdrawn |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 | |
| 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 |
NCT01525836 -
rhTPO Combining Rituximab Versus Low-dose Rituximab in Management of ITP
|
Phase 3 | |
| 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 |