Idiopathic Thrombocytopenic Purpura Clinical Trial
Official title:
A Phase 3, Multicenter, Randomized, Double-blind, Active-controlled, Parallel-group Trial With an Open-label Extension Phase to Evaluate the Efficacy and Safety of Oral E5501 Versus Eltrombopag, in Adults With Chronic Immune Thrombocytopenia (Idiopathic Thrombocytopenic Purpura)
Core study:
To compare the efficacy of avatrombopag (in addition to standard) of care to eltrombopag (in
addition to standard of care) for the treatment of adult participants with chronic immune
thrombocytopenia (idiopathic thrombocytopenic purpura [ITP]) as measured by durable platelet
response.
Open-label Extension Phase:
To evaluate the safety and tolerability of long-term therapy with avatrombopag in
participants with chronic ITP (cITP).
The study consists of three phases: Prerandomization, Randomization (Core Study) and Extension Phase. Participants 18 years of age and over, who meet all the eligibility requirements will be randomized into the study. It will require that splenectomized participants make up at least 35% of the study population and no single platelet count is greater than 35x10^9/L. Participants will be centrally stratified at randomization by splenectomy status, baseline platelet count, and use of concomitant ITP medication at baseline and randomized to receive either double-blind avatrombopag or eltrombopag in a 1:1 ratio. Participants will receive blinded therapy at a starting dose of 20 mg avatrombopag once daily or 50 mg eltrombopag once daily. Participants will be allowed to have their dose titrated up (maximum dose 40 mg avatrombopag and 75 mg for eltrombopag) or down (minimum dose 5 mg for avatrombopag and 25 mg for eltrombopag) depending on their response to study drug. The goal of dose modification is to maintain the platelet count at levels greater than or equal to 50x10^9/L and less than or equal to 150x10^9/L, and to decrease the need for ITP-directed concomitant medications. The duration of treatment in the Core study and the Extension Phase is approximately 26 and 104 weeks, respectively. ;
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Withdrawn |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 |
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 |
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 |
NCT00475423 -
A Study of MabThera (Rituximab) in Patients With Idiopathic Thrombocytopenic Purpura.
|
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 | |
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 |